Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013188547

FEI Number

3013188547

Entity Name

ORTA MEDICAL LTD

City/State/Country

TZUR YIGAL Central, IL

Establishment Address

BAZELET 14, TZUR YIGAL Central 44862, IL

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ORTA MEDICAL LTD (Owner Number: 10053784)

Owner / Operator Contact Address

BAZELET 14, ZUR IGAL, IL-NOTA 44862, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORTA MEDICAL ORTA MEDICAL ORTA MEDICAL ORTA MEDICAL ORTA MEDICAL SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID URISCREEN 6L STRIP 10S URISCAN 10 SGL STRIP 774 UNISCAN 10 SGL STRIP 10 S ORTA MEDICAL ENDO CATCH GOLD Verastep Laparoscope, general & plastic surgery VERASTEP ORTA MEDICAL ORTA MEDICAL shiley covidian ORTA MEDICAL Ophthalmoscope, ac-powered ORTA MEDICAL ORTA MEDICAL Non-surgical isolation gown hylard Device, medical examination, ac powered Laparoscope, general & plastic surgery ORTA MEDICAL ORTA MEDICAL ORTA MEDICAL Shiley Disposable Cannula Trach. Tube SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated ORTA MEDICAL Shiley ERA - OTOSCOPE ORTA MEDICAL Gauze / sponge,nonresorbable for external use ORTA MEDICAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-09-03
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2023-07-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-09-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-12-29
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2021-01-13
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-01-13
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2019-07-08
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2021-04-27
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2019-04-24
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2020-12-23
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2020-12-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-12-09
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2024-02-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-09-04
KCM	Dropper, Ent	Ear, Nose, Throat	Class 1	874.5220	2023-10-12
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-12-29
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2018-08-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-09-24
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2019-04-24
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2022-12-21
GXB	Esthesiometer	Neurology	Class 1	882.1500	2022-11-07
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2025-09-24
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2018-03-17
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2017-11-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-11-10
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-01-13
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2020-03-16
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2018-04-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-03-10
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-08-21
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2025-08-21
KDW	Container, Specimen Mailer And Storage, Temperature Controlled, Sterile	Pathology	Class 1	864.3250	2018-04-26
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2023-03-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-02-09
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2023-03-14
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-10-26
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2020-03-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-01-22
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2021-04-27
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-04-27
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2020-10-16
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2019-12-30
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2019-04-16
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2023-03-14
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2017-07-13
KXP	Stent, Vaginal	Obstetrics/Gynecology	Class 2	884.3900	2023-03-02
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2026-04-23
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Gastroenterology, Urology	Class 2	876.1500	2017-11-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-04-24
FIQ	Cannula, A-V Shunt	Gastroenterology, Urology	Class 2	876.5540	2020-08-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-04-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-09-04
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2019-07-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-07-10
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-11-23
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2018-03-14
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2019-04-24
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2020-08-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-09-24
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2023-09-10
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2019-07-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-09-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-09-08
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-09-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-09-08
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2022-12-01
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-08-05
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2018-08-09
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2020-02-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-09-04
OMD	Cutaneous Tissue Adhesive With Mesh	General, Plastic Surgery	Class 2	878.4011	2020-03-16
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2017-07-15
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2022-08-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-02-25
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2019-09-25
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2025-09-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-07-18
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2022-09-29
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2025-07-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-09-12
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2024-01-21
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2019-12-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-12-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-01-11
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2018-03-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-08-09
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2020-05-18
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-04-26
ORQ	Mesh, Surgical, Deployer	General, Plastic Surgery	Class 2	878.3300	2019-04-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-05-30
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2020-09-09
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-03-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-12-09
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2019-04-24
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2020-02-13
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2019-04-24
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-09-17
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2017-07-26
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2020-02-13
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-09-24
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2024-06-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-01-20
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2020-03-25
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-09-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-10-25
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2022-11-28
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2018-08-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-02-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-07-10
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2020-04-07
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2019-07-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-08-28
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-08-28
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2023-03-02
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2020-08-12
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2023-04-10
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2017-07-24
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2019-07-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-12-29
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2018-03-14
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-09-03
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2024-02-13
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2019-12-30
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2023-03-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-10-16
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-08-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-02-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-12-28
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2022-12-21
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-07-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-11-09
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2025-09-24
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-10-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-07-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-09-03
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2019-09-02
FOK	Pad, Neonatal Eye	General Hospital	Class 1	880.5270	2020-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

ORTA MEDICAL LTD

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

View Entity Profile →

Related 510(k) Records

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K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013188547. Last updated year: 2026. Please use registration number 3013188547 when referencing this establishment in official correspondence.