Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010131137

FEI Number

3010131137

Entity Name

BIOTRONIX HEALTHCARE INDUSTRIES INC.

City/State/Country

Orlando, FL, US

Establishment Address

4700 Millenia Blvd Ste 500, Orlando, FL 32839, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Biotronix Healthcare Industries Inc. (Owner Number: 10043487)

Owner / Operator Contact Address

4700 Millenia Blvd Suite 500, Orlando, FL 32839, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Biotronix Healthcare Nephrostomy Catheters Biotronix Healthcare Thorasic Catheters Biotronix Healthcare Show Covers Bio-Chamber Spacer Biotronix Healthcare Bellota Sonohysterography Catheter UIC Biotronix Healthcare Ear/Ulcer Syringe Biotronix Healthcare Irrigation Tray Biotronix Healthcare Bulb Syringe Biotronix Healthcare Enteral Feeding Syringe Biotronix Healthcare Staple Removal Tray Biotronix Healthcare Suture Removal Tray Biotronix Healthcare Peritoneal Catheter Biotronix Healthcare Uterine Sound Biotronix Healthcare X-Ray Film Illuminators Biotronix Healthcare Ventilation Cicuit w/ Two Water Traps, Limb, Bacterial Filter, Catheter Mount Biotronix Healthcare Bioflow Circuits w/Gas Sampling Line, Breathing Bag, Epandible Limb, Filter Biotronix Healthcare Ventilator Circuit Biotronix Healthcare Bioflow Circuits w/ Breathing Bag, Epandible Limb Biotronix Healthcare Ventilation Cicuit Smooth Bore w/ Two Water Traps, Limb Biotronix Healthcare Bio Flow Circuit w/Expandable Limb, Gas Sampling Line, Breathing Bag, Filter, Mask Biotronix Healthcare Proximinal Line Cicuit Smooth Bore w/ Limb Biotronix Healthcare Ventilation Expandable Cicuit w/ Two Water Traps, Limb Biotronix Healthcare Ventilation Cicuit Corrugated w/ Water Traps, Limb Biotronix Healthcare Ventilation Cicuit Corrugated Biotronix Healthcare Proximinal Line Cicuit Corrugated w/ Limb Biotronix Healthcare Ventilation Circuits Smooth Bore Biotronix Healthcare Ventilation Cicuit w/ Two Water Traps, Limb Biotronix Healthcare Bioflow Circuits Biotronix Healthcare Bioflow Circuits w/Gas Sampling Line, Breathing Bag, Mask, Expandible Limb Biotronix Healthcare Endotracheal Tube with Evacuation Lumen Biotronix Healthcare Mucus Extractor 40ml Biotronix Healthcare Mucus Extractor 25ml Biotronix Healthcare Trachestomy Trays Biotronix Healthcare Poliglecaprone 25 Biotronix Healthcare Disposable Linear Staplers and Reloads Biotronix Healthcare Disposable Endoscopic Linear Cutter Staplers and Reloads Biotronix Healthcare Disposable Linear Cutter Staplers and Reloads Biotronix Healthcare Disposable Circular Stapler Biotronix Healthcare Disposable Curved Cutter Stapler Biotronix Healthcare Disposable Hemorrhoid Stapler Biotronix Healthcare Silk Suture with Needle Biotronix Healthcare balloon Catheter Biotronix Healthcare Surgical Scrb Brush Biotronix Healthcare Tongue Deppressor Pediatric, Sterile Biotronix Healthcare Tongue Deppressor Adult, N/S Biotronix Healthcare Tongue Deppressor Adult, Sterile Biotronix Healthcare Tongue Deppressor Pediatric, N/S Biotronix Healthcare Nonabsorbable Polyester Suture with Needle Biotronix Healthcare Nonabsorbable Silk Suture with Needle Biotronix Healthcare Nonabsorbable Nylon Suture with Needle Biotronix Healthcare Nonabsorbable Polypropylene Suture with Needle Biotronix Healthcare IV Catheter Biotronix Healthcare Multiple Rebreathing Bags Biotronix Healthcare High Pressure Injector Syringes Biotronix Healthcare Nebulizer Pump ANT-S600MG Biotronix Healthcare Nebulizer Pump ANT-S600MC Biotronix Healthcare Nebulizer ANT-S600A Biotronix Healthcare Nebulizer Pump ANT-S600MH Biotronix Healthcare Nebulizer Pump ANT-S600C Biotronix Healthcare Nebulizer Pump ANT-S600DII Biotronix Healthcare Nebulizer Pump ANT-S600MA Biotronix Healthcare Nebulizer Pump ANT-S600B Biotronix Healthcare Absorbable Polyglycolic Acid Suture with Needle Biotronix Healthcare Absorbable Polydioxanone Suture with Needle Regular Blood Collection Set Biotronix Healthcare Monitoring Electrodes Biotronix Healthcare ECG Electrodes Biotronix Healthcare Resting Tab Electrodes Biotronix Healthcare Pediatric ECG Electrodes Biotronix Healthcare Silver ECG Electrodes Biotronix Healthcare Stress Test Electrodes Electrodes Biotronix Healthcare Clip Electrodes Biotronix Healthcare Neonatal ECG Electrodes Biotronix Healthcare Bio-Guard Safety Multi-Sample Needle all sizes Biotronix Healthcare Bio-Guard Safety Multi-Sample Needle with pre-attached holder all sizes Biotronix Healthcare T Drain Biotronix Healthcare Closed Suction Catheters Biotronix Healthcare Thorasic Silicone Drains Biotronix Healthcare Suction Yankauer Biotronix Healthcare Suction Catheters Biotronix Healthcare Suction Yankauer with Tube Biotronix Healthcare Thorasic Catheters Biotronix Healthcare Suction Tubes Biotronix Healthcare Blood Collection Tube No Additive Biotronix Healthcare SSMMSS Level 3 Surgical Gowns Biotronix Healthcare Polydioxanone Suture with Needle Biotronix Healthcare Stainless Steel Scalpel Blades Biotronix Healthcare Carbon Steel Scalpel Blades Biotronix Healthcare Suction Connection Tube Biotronix Healthcare Bio-Guard Safety IV Catheter all sizes Biotronix Healthcare Nebulizer w/ Neonate Mask, 7FT Tubing, Universal Connector Biotronix Healthcare Nebulizer w/ Mouthpiece, 7FT Tubing, Universal Connector Biotronix Healthcare Nebulizer w/ Pediatric Mask, 7FT Tubing, Standard Connector Biotronix Healthcare Nebulizer w/ Mouthpiece, 7FT Tubing, Standard Connector Biotronix Healthcare Nebulizer w/ Adult Mask, 7FT Tubing, Universal Connector Biotronix Healthcare Nebulizer w/ Noenate Mask, 7FT Tubing, Standard Connector Biotronix Healthcare Nebulizer w/ Pediatric Mask, 7FT Tubing, Universal Connector Biotronix Healthcare Nebulizer w/ Adult Mask, 7FT Tubing, Standard Connector Biotronix Healthcare HCG Test Biotronix Healthcare HCG Urine Pregnancy Test Cassette Biotronix Healthcare Suture Removal Tray Biotronix Healthcare Shave Prep Tray Biotronix Healthcare Dressing Change Tray Biotronix Healthcare IV Start Kit(Tray) Biotronix Healthcare Tracheostomy Care Tray Biotronix Healthcare Staple Removal Tray Biotronix Healthcare Circumcision Trays Biotronix Healthcare Pelvic Exam Trays Biotronix Healthcare Dry Skin Scrub Prep Trays Biotronix Healthcare Debridement Trays Biotronix Healthcare Central Line Dressing Tray Biotronix Healthcare Minor Laceration Trays Biotronix Healthcare Incision and Drainage Trays Biotronix Healthcare Dry Eye Prep Trays Biotronix Healthcare Hydrogel Dressing Biotronix Healthcare Colostomy Pouch, Single Piece, Drainable Biotronix Healthcare Colostomy Pouch, Two Piece Biotronix Healthcare Colostomy Pouch, Two Piece, Drainable Biotronix Healthcare Colostomy Pouch, Single Piece Biotronix Healthcare Prefilled Sterile Water Syringes Biotronix Healthcare Hydrophic Coated Guidewire Biotronix Healthcare Stainless Steel Guidewire Biotronix Healthcare PTFE Coated Guidewire Biotronix Healthcare Insulin Pen Needles Biotronix Healthcare Cotton Roll Biotronix Healthcare Urine Collection Leg Bags Biotronix Healthcare Latex T Drains Biotronix Healthcare Silicone T Drains Biotronix Healthcare Silicone JP Drains Biotronix Healthcare Silicone Round Drains Biotronix Healthcare Silicone Flat Drains Biotronix Healthcare Prefilled Lubricating Gel Syringe Biotronix Healthcare Strep A Strip Test Biotronix Healthcare Strep A Cassette Test Biotronix Healthcare Oxygen Non-Rebreather Mask Biotronix Healthcare Oxygen 3-in-1 Mask Biotronix Healthcare Surgical Mask Biotronix Healthcare IV Administration Sets Biotronix Healthcare Latex Surgical Gloves Biotronix Healthcare Safety Needles, Syringes with Safet Needles Biotronix Healthcare Pediatric Tracheostomy Mask w/ Standard Connector Biotronix Healthcare Pediatric Tracheostomy Mask w/ Universal Connector Biotronix Healthcare Adult Tracheostomy Mask w/ Universal Connector Biotronix Healthcare Adult Tracheostomy Mask w/ Standard Connector Biotronix Healthcare Sterile Cotton Tipped Applicator Biotronix Healthcare Deluxe Urine Drainage Bags 200ml Biotronix Healthcare Disposable Electrosurgical Button Controls Bi-Polar Coagulating Pencil Biotronix Healthcare Disposable Electrosurgical Rocker Controls Pencil Biotronix Healthcare Reusable Electrosurgical Button Controls Pencil Biotronix Healthcare Disposable Electrosurgical Button Controls Bi-Polar Cutting Pencil Biotronix Healthcare Disposable Electrosurgical Button Controls Pencil Biotronix Healthcare Disposable Electrosurgical Foot Controls Pencil Biotronix Healthcare Eustachian Catheter Biotronix Healthcare Sutures Needle Biotronix Healthcare Island Dressing, Sterile, 6"x6" Biotronix Healthcare Island Dressing, Sterile, 2"x31/2", Biotronix Healthcare Gauze Sponges, N/S, 4"x4", 12 ply Biotronix Healthcare Gauze Rolls 36" x 100yds 19x15, X-Ray Detectable, N/S Biotronix Healthcare Gauze Sponges, N/S, 3"x3", 8 ply Biotronix Healthcare Gauze Sponges, N/S, 2"x2", 8 ply Biotronix Healthcare Ultra Gauze Bandages Rolls Sterile Biotronix Healthcare Gauze Rolls 36" x 100yds 20x12, X-Ray Detectable, N/S Biotronix Healthcare Gauze Rolls 36" x 100yds 24x20, X-Ray Detectable, N/S Biotronix Healthcare Gauze Rolls 90cm x 100m, 30x20, N/S Biotronix Healthcare Conforming Gauze Bandages N/S Biotronix Healthcare Gauze Sponges, N/S, 4"x4", 8 ply Biotronix Healthcare Ultra Gauze Bandages Rolls N/S Biotronix Healthcare Gauze Rolls 36" x 100yds 24x20, N/S Biotronix Healthcare Abdominal Pads ABD Biotronix Healthcare Wound Skin Closures Biotronix Healthcare Surgical Tapes Biotronix Healthcare Adhesive Elastic Bandages Biotronix Healthcare Gauze Sponges Various Biotronix Healthcare Non-Woven Gauze Sponges 4"x4" Biotronix Healthcare Gauze Sponges, Sterile, 4"x4", 12 ply Biotronix Healthcare Gauze Sponges, Sterile, 4"x4", 16 ply Biotronix Healthcare Non-Woven Gauze Sponges 2"x2" Biotronix Healthcare Gauze Sponges, N/S, 3"x3", 12 ply Biotronix Healthcare Non-Woven Gauze Sponges 3"x3" Biotronix Healthcare Non-Adherent Gauze Pads, Sterile, 3"x4" Biotronix Healthcare Gauze Sponges, N/S, 4"x4", 16 ply Biotronix Healthcare Conforming Gauze Bandages Sterile Biotronix Healthcare Gauze Rolls 36" x 100yds 19x15, N/S Biotronix Healthcare Gauze Rolls 36" x 100yds 20x12, N/S Biotronix Healthcare Non-Adherent Gauze Pads, Sterile, 2"x3" Biotronix Healthcare Gauze Rolls 90cm x 100m, 20x12, N/S Biotronix Healthcare Gauze Sponges, N/S, 4"x8", 12 ply Biotronix Healthcare Gauze Sponges, Sterile, 2"x2", 12 ply Biotronix Healthcare Gauze Sponges, Sterile, 4"x4", 8 ply Biotronix Healthcare Gauze Sponges, Sterile, 3"x3", 12 ply Biotronix Healthcare Gauze Sponges, Sterile, 2"x2", 8 ply Biotronix Healthcare Island Dressing, Sterile, 4"x4" Biotronix Healthcare Gauze Sponges, N/S, 2"x2", 12 ply Biotronix Healthcare Gauze Sponges, Sterile, 3"x3", 8 ply Biotronix Healthcare Non-Adherent Gauze Pads, Sterile, 3"x8" Biotronix Healthcare Insulin Syringes with needle Biotronix Healthcare Nylon Suture with Needle Biotronix Healthcare Word/Bartholin Catheter set Biotronix Healthcare Pediatric Heat and Moisture Exchangers (HME) Biotronix Healthcare Trach Heat and Moisture Exchangers (HME) Biotronix Healthcare Adult Heat and Moisture Exchangers (HME) Biotronix Healthcare Linear Cutter 60/80/100 Biotronix Healthcare Linear Stapler 30/60/90 Biotronix Healthcare Non-Sterile Specimen Container Biotronix Healthcare Legacy Oral Feeding Syringes Biotronix Healthcare Bioflow Circuits w/Gas Sampling Line, Breathing Bag, Mask, Epandible Limb Biotronix Healthcare Bioflow Circuits w/Gas Sampling Line, Breathing Bag, Mask, Filter, Epandible Limb Biotronix Healthcare Dual Limb Circuits Expandable Biotronix Healthcare Dual Limb Expandable Cicuit w/accessories Verox Bi-Lumen Circuits Biotronix Healthcare Verox Breathing Circuit w/accessories Biotronix Healthcare Corrugated Dual Limb Circuits w/ filter, breathing bag, mask Biotronix Healthcare Corrugated Dual Limb Circuits w/ accessories Biotronix Healthcare Bioflow Circuits w/ Breathing Bag, Mask, Epandible Limb, Filter Biotronix Healthcare Smooth Bore Dual Limb Circuits w/ filter, breathing bag, mask Biotronix Healthcare Smooth Bore Dual Limb Circuits w/ accessories Biotronix Healthcare Dual Limb Expandable Circuit w/Filter, Breathing Bag, Mask Biotronix Healthcare Bioflow Circuits w/Gas Sampling Line, Breathing Bag, Epandible Limb Biotronix Healthcare Dental Film Biotronix Healthcare Mammography Film Biotronix Healthcare Blue Sensitive X-Ray Film Biotronix Healthcare CT Film Biotronix Healthcare Green Sensitive X-Ray Film Norvich Health 1cc, 3cc, 5cc, 10cc, 20cc, 30cc, 50cc, 60cc luer slip and luer lock with and without needle Biotronix Healthcare 1cc, 3cc, 5cc, 10cc, 20cc, 50cc, 30cc,60cc, luer slips and luer lock, with and without needle Biotornix Healthcare Pencil Point Needle Biotornix Healthcare Epidural Touhy Needle Biotornix Healthcare Quincke Spinal Needle Biotronix Healthcare Airway Connector Biotronix Healthcare Colostomy Appliance Biotronix Healthcare Bio-Guard Safety Needles and Syringes with Bio-Guard Safety Needles Biotronix Healthcare Paper Tape Biotronix Healthcare Silk Tape Biotronix Healthcare Steri Strips Biotronix Healthcare Zinc Oxide Tape Biotronix Healthcare Fabric Adhesive Bandages Biotronix Healthcare Island Dressing Biotronix Healthcare Transparent Tape Biotronix Healthcare Plastic Adhesive Bandages Biotronix Healthcare Latex Breathing Bag Biotronix Healthcare Neoprene Breathing Bag Biotronix Healthcare Latex Free Breathing Bag Biotronix Healthcare Radial Introducer Kit Biotronix Healthcare Long Sheath Introducer Kit Biotronix Healthcare Femoral Introducer Kit Biotronix Healthcare Pediatric Urine Bag, Adhesive Biotronix Healthcare Urine Leg Drainage Bag 1000ml Biotronix Healthcare Urine Leg Drainage Bag 500ml Biotronix Healthcare Deluxe Urine Dranage Bag 2000ml Biotronix Healthcare 2000ml Urine Collection Bag Biotronix Healthcare Urostomy Bag 1 piece Biotronix Healthcare Urostomy Bags Biotronix Healthcare Urostomy Bag 2 piece Biotronix Healthcare Dual Lumen Nasal Cannula Biotronix Healthcare Nasal Cannula Biotronix Healthcare Parraffin Gauze Biotronix Healthcare Vaseline Gauze Biotronix Healthcare Xeroform Gauze Biotronix Healthcare Hydrocolloid Dressings all sizes Biotronix Healthcare Transparent Dressings all sizes Biotronix Healthcare Suture Removal Tray Biotronix Healthcare Diluting Pipette Biotronix Healthcare Anesthesia Mask Biotronix Healthcare Collection Trap Biotronix Healthcare Mechanical Adult Bacterial Viral Filter, with and without Sampling Port Biotronix Healthcare Pediatric Healt and Moister Exchange Filter (HMEF), with and without Sampling Port Biotronix Healthcare Mechanical HEPA Bacterial Viral Filter, with and without Sampling Port Biotronix Healthcare Adult Healt and Moister Exchange Filter (HMEF), with and without Sampling Port Biotronix Healthcare Mechanical Pediatric Bacterial Viral Filter, with and without Sampling Port Biotronix Healthcare Marijuana Urine Test Biotronix Healthcare Cocaine Urine Test Biotronix Healthcare Bio-Q Plus Blood Glucose Monitoring System Biotronix Healthcare Bio-Q One Blood Glucose Monitoring System Biotronix Healthcare Nebulizer Mouth Piece Biotronix Healthcare Mouthpiece Biotronix Healthcare Face Tent Biotronix Bio-Guard Safety Multi-Sample Needles Biotronix Bio-Guard Safety Multi-Sample Needles with Pre-Attached Holder Biotronix Healthcare Urine Bags Biotronix Healthcare Monitroring Pads Biotronix Healthcare Lead Wire Biotronix Healthcare Defribrillation Electrodes Biotronix Healthcare Polyester Suture with Needle Biotronix Healthcare Colostomy Drainage Bag With Adhesive Biotron Healthcare Pressure Tubing Biotronix Healthcare Microscope Slide cover Biotronix Healthcare Chest Drainage System Water seal Biotronix Healthcare Thorasic Seal Biotronix Healthcare Polyglactine 910 Biotronix Healthcare OR Towles Biotronix Healthcare Absorbent Underpad Biotronix Healthcare Microbiological Transport System, W/Ames and CH Biotronix Healthcare Microbiological Transport System, Cary Blair Biotronix Healthcare Microbiological Transport System, W/Ames and W/O CH Biotronix Healthcare Microbiological Transport System, Stuart Biotronix Healthcare Microbiological Transport System, w/o Media Biotronix Healthcare Microbiological Transport System, Biotronix Healthcare Syringes and needles Biotronix Healthcare Silicone Vaginal Dilator Biotronix Healthcare Pressary Remover Biotronix Healthcare Parker Flex-tip Endotracheal Tube Biotronix Healthcare Endobronchial Blocker Tube Biotronix Healthcare Endobronchial Tube Biotronix Healthcare Tissue Culture Flasks Biotronix Healthcare Tissue Culture Chamber Biotronix Healthcare Tissue Culture Dishes NeoStick Safety Neonate Lancets Biotronix Healthcare Sahli Pipette Biotronix Healthcare Spinner Flask Biotronix Healthcare Capillary safety Lancet Biotronix Healthcare Stainless Steel Lancet Biotronix Neo-Stick Preemie Safety Lancet Biotronix Neo-Stick Neonate Safety Lancet Biotronix Healthcare Lap Sponges , Sterile, 8"x36" Biotronix Healthcare Packing Strip Biotronix Healthcare Peanut Sponges Biotronix Healthcare Lap Sponges , Sterile, 18"x18" Biotronix Healthcare Lap Sponges , Sterile, 4"x18", w/Barrium Strip Biotronix Healthcare OR Towles Biotronix Healthcare Lap Sponges , Sterile, 4"x18" Biotronix Healthcare Tonsil Sponges Biotronix Healthcare Lap Sponges , Sterile, 18"x18", w/Barrium Strip Biotronix Healthcare Lap Sponges Biotronix Healthcare Lap Sponges , Sterile, 12"x12", w/Barrium Strip Biotronix Healthcare Stick Sponges Biotronix Healthcare X-Ray Detectable Gauze Sponges Biotronix Healthcare Lap Sponges , Sterile, 8"x36", w/Barrium Strip Biotronix Healthcare Lap Sponges , Sterile, 12"x12" Biotronix Healthcare Tracheal Tube Stylet Biotornix Healthcare AV Safety Fistula Needle Biotronix Healthcare HSG Catheter Sets Biotronix Healthcare Powderfree Surgeons Gloves Biotronix Healthcare Reinforced Endotracheal Tubes Cuffed Biotronix Healthcare Reinforced Endotracheal Tubes Un-Cuffed Biotronix Healthcare Closed Suction Catheter Biotronix Healthcare Suction Catheter Biotronix Healthcare 72 Hour Closed Suction Catheter Biotronix Healthcare 24 Hour Closed Suction Catheter Suction Catheter Trays all types Biotronix Healthcare Continuous Irrigation Catheter Biotronix Healthcare Elastic Bandages Biotronix Healthcare Staple Remover Biotronix Healthcare Inflation Device Kit Biotronix Healthcare Gravity Enteral feeding Set with EnFit Connector Biotronix Healthcare Pump Set with EnFit Connector Biotronix Healthcare Pump Bag Set with EnFit Connector Biotronix Healthcare Surgical Apparel Biotronix Healthcare Face Shield Sci-Q Radial Artery Compression Tourniquet Biotronix Healthcare Radial Artery Compression Tourniquet Biotronix Healthcare Sump Drain Biotronix Healthcare Silicone Flat Drain Biotronix Healthcare Silicone Round Drain Biotronix Healthcare Thorasic Catheters Biotronix Healthcare Uterine Manipulator / Injector 4.5 and 4.5I Biotronix Healthcare Aerosol Mask Biotronix Healthcare Venturi Mask Biotronix Healthcare High Concentration Oxygen Mask Biotronix Healthcare MultiVent Venturi Mask Biotronix Healthcare Central Venous Catheters and Kits Biotronix Healthcare Flowmeter Biotronix Healthcare Cover Slips and Microscope Slides all types Biotronix Healthcare Ureteral Stylet Biotronix Healthcare Ileostomy Bag Biotronix Healthcare Urostomy Pouch Bag Biotronix Healthcare Powder Free Latex Medical Examination Gloves with Protein Labeling (50 micrograms or less) Biotronix Healthcare Soda Lime Biotronix Healthcare Nebulizer sets Adult, Pediatric Biotronix Healthcare IV Catheters Biotronix Healthcare Chromic Catgut Suture with Needle Biotronix Healthcare Plain Catgut Suture with Needle Biotronix Healthcare Nasal Cannulas Norvich Health Nasal Cannulas Biotronix Healthcare Surgical Prep Razor Biotronix Healthcare Blood Collection Tubes Biotronix Healthcare Double Pigtail Ureteral Stent with and without suture Biotronix Healthcare Polypropylene Suture with Needle Biotronix Healthcare Silicone Foley Catheters w/Temperature Probe Biotronix Healthcare Circular Staplers Biotronix Healthcare Tissue Culture Flasks Biotronix Healthcare Polypropylene Surgical Mesh Biotronix Healthcare Suction Canister Biotronix Healthcare Polyglycolic Acid Suture with Needle Biotronix Healthcare Multiple esophageal Stethescopes Biotronix Healthcare Surgical Cap Biotronix Healthcare Electrosurgical Adult Bi-Polar Patient Plates Biotronix Healthcare Electrosurgical Adult Monopolar Patient Plates Biotronix Healthcare Electrosurgical Neonate Monopolar Patient Plates Biotronix Healthcare Electrosurgical Child Bi-Polar Patient Plates Biotronix Healthcare Electrosurgical Neonate Bi-Polar Patient Plates Biotronix Healthcare Electrosurgical Child Monopolar Patient Plates Biotronix Healthcare Biosorb Biotronix Healthcare Carbon-Dioxide Absorber Biotronix Bio-Guard Slide Safety Blood Collection Set Biotroni Bio-Guard Slide Safety Blood Collection Set with Pre-Attached Holder Biotronix Healthcare Biopsy Devices Biotronix Healthcare Cholangiography Catheter Biotronix Healthcare Silicone Penrose Tube Biotronix Healthcare Latex Penrose Tube Biotronix Healthcare Endometrial Sampling Stiff Curette Set Biotronix Healthcare Endometrial Sampling Flexible Curette Sets Biotronix Healthcare Endotracheal Tube Holder Biotronix Healthcare Examination Gowns Biotronix Healthcare EnFit Syringes and Pharmacy Syringes Biotronix Healthcare Micro Pipette Biotronix Healthcare Plaster of Paris Biotronix Healthcare Underpadding Biotronix Healthcare Marijuana Test Strip Biotronix Healthcare One Step Marijuana Test Cassette Biotornix Healthcare AV Fistula Needle Set Biotronix Healthcare Vaginal Pressaries Biotronix Healthcare IV Sart Kits and Trays Biotronix Healthcare Quantitative Pipette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2013-03-22
GBN	Catheter, Pediatric, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2013-03-22
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2013-02-24
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2020-03-25
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2014-06-08
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2013-03-02
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2021-04-20
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2013-02-22
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2014-06-08
IXC	Illuminator, Radiographic-Film	Radiology	Class 1	892.1890	2013-02-24
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2013-02-22
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2013-04-14
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-04-14
LRQ	Tracheostomy And Nasal Suctioning Kit	Unknown	Class 1	N/A	2021-04-20
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2014-04-09
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2015-06-20
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2013-03-29
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2013-03-22
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2013-03-03
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2013-03-03
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2013-03-27
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2013-03-27
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-03-27
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2013-03-27
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2013-05-17
BYW	Device, Rebreathing	Anesthesiology	Class 1	868.5675	2013-02-24
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2015-06-14
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2014-03-14
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2013-03-27
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2013-03-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-02-23
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-02-23
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2013-03-09
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-12-29
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2013-03-09
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2013-03-03
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-05-07
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2013-03-29
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-02-24
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2013-03-09
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-12-29
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2013-02-24
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2014-03-15
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2014-03-15
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2016-07-09
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2013-02-24
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2013-03-03
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2021-04-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-06-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-12-16
EFN	Cotton, Roll	Dental	Class 1	872.6050	2013-03-03
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-02-22
GBP	Catheter, Multiple Lumen	General, Plastic Surgery	Class 1	878.4200	2013-03-24
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2016-07-09
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2014-03-15
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2013-02-22
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2013-03-10
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-02-26
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2014-03-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-03-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-03-14
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2022-03-14
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2013-03-09
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2013-02-24
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2013-03-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-05-17
GBY	Catheter, Eustachian, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2013-03-24
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-03-22
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2013-02-24
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-12-16
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2013-03-29
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2014-06-08
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2013-02-24
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2014-06-08
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2013-02-24
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2025-02-23
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2013-02-24
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2013-02-24
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-12-16
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2015-09-26
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2013-03-03
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2013-03-22
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-03-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-03-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-03-13
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-02-24
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2013-02-24
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-04-09
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2013-03-03
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2013-02-24
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2013-02-24
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2016-07-09
GGY	Pipette, Diluting	Hematology	Class 1	864.6160	2013-03-03
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2013-02-22
CBC	Bottle, Collection And Trap, Breathing System (Uncalibrated)	General Hospital	Class 2	880.6740	2013-03-22
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2021-04-20
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2014-03-15
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2014-03-15
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-06-14
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-06-14
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-06-14
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2013-02-24
BYL	Tent, Oxygen	Anesthesiology	Class 1	868.5700	2013-02-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-01-10
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2021-01-10
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-02-22
MLN	Electrode, Electrocardiograph, Multi-Function	Cardiovascular	Class 2	870.2360	2013-03-09
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-03-29
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2013-03-03
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2013-02-22
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2013-02-24
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2013-03-09
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2014-04-09
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2013-02-24
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2013-03-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-12-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-12-30
HDX	Dilator, Vaginal	Obstetrics/Gynecology	Class 2	884.3900	2014-06-08
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2014-06-08
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2013-03-10
KIY	Chamber, Slide Culture	Hematology	Class 1	864.2240	2013-06-22
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-02-23
GGX	Pipette, Sahli	Hematology	Class 1	864.6160	2013-03-03
KJD	Spinner, Flask	Hematology	Class 1	864.2240	2013-06-22
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2013-03-03
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2013-02-24
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2013-02-22
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2015-09-26
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2015-09-26
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2014-06-08
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2014-08-23
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-04-14
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2013-02-20
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2013-03-22
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2013-03-03
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2013-02-24
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2015-06-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2021-04-20
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2021-04-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2013-02-24
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2014-04-09
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2013-03-22
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2014-06-08
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2013-02-24
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2013-05-17
CCN	Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge	Anesthesiology	Class 1	868.2300	2013-02-24
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2013-06-22
EYA	Stylet, Ureteral	Gastroenterology, Urology	Class 1	876.5130	2013-02-22
EXH	Bag, Urinary, Ileostomy	Gastroenterology, Urology	Class 1	876.5900	2013-03-03
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2014-03-19
BSF	Absorber, Carbon-Dioxide	Anesthesiology	Class 1	868.5310	2013-03-22
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2015-12-16
JCY	Catheter, Infusion	General, Plastic Surgery	Class 1	878.4200	2013-02-24
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2013-03-29
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2013-02-22
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-03-03
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-03-03
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2015-09-26
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2013-03-29
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2013-03-09
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2014-06-08
KJA	Flask, Tissue Culture	Hematology	Class 1	864.2240	2013-06-22
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2013-03-30
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2013-03-09
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2013-03-29
BZW	Stethoscope, Esophageal	Anesthesiology	Class 1	868.1910	2013-02-24
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2013-02-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-05-17
CBL	Absorbent, Carbon-Dioxide	Anesthesiology	Class 1	868.5300	2013-02-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-01-10
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	Class 1	878.4800	2015-09-26
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2013-03-22
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-02-24
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2014-06-08
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2013-03-03
FME	Gown, Examination	General Hospital	Class 1	880.6265	2013-03-03
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2025-02-23
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2013-06-22
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2013-02-24
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2014-03-15
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2015-09-26
HHW	Pessary, Vaginal	Obstetrics/Gynecology	Class 2	884.3575	2014-06-08
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2021-04-20
GJG	Pipette, Quantitative, Hematology	Hematology	Class 1	864.6160	2013-03-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biotronix Healthcare Industries Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

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Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010131137. Last updated year: 2026. Please use registration number 3010131137 when referencing this establishment in official correspondence.