Integra Biotechnical, SA de CV

FDA Device Registration & Listing · Tijuana Baja California, MX · Registration 3009746061

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009746061
FEI Number
3009746061
Entity Name
Integra Biotechnical, SA de CV
City/State/Country
Tijuana Baja California, MX
Establishment Address
Privada Los Pinos #17030 Interior 15, 16, 17, Colonia Ninos Heroes Este, C.P, Ave. Via Rapida Poniente #16835 Interior 3, Centro Ind. Los Pinos II, Colonia Ninos Heroes Este, C.P., Tijuana Baja California 22120, MX
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Amphenol Critical Medical Technologies, LLC (Owner Number: 9030406)
Owner / Operator Contact Address
9586 Distribution Avenue, Suite F, San Diego, CA 92121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Miser Contrast Management 20-1615-10 BXPU636 R8704 RE7517 20-1620-12 R8772 20-1520-18L BXPU516 3104 20-1500-24 BXPU536 BXPU816 SA0300015 BXPU424 200795-001 ZTUBG-075 10-1550 BXPU524 200603-001 R8774 BXPU616 20-1500-18 BXPU624 20-1500-09 20-1615-10F 1025569 BXPU836 ZTUBG076 20-1520-18 200684-001 BXPU824 10-1550-001 010-062 Part Numbers BXPU416 20-1500-12 3901-1020 1019974 R8731 POWERWAND XL 4Fr 8cm Extended Dwell Catheter POWERWAND XL 5Fr 10cm Extended Dwell Catheter 5 Fr 10cm POWERWAND Safety Introducer with Extended Dwell Catheter 4 Fr 10cm POWERWAND Safety Introducer with Extended Dwell Catheter POWERWAND XL 5Fr 8cm Extended Dwell Catheter 5 Fr 8cm POWERWAND Safety Introducer with Extended Dwell Catheter 4 Fr 8cm POWERWAND Safety Introducer with Extended Dwell Catheter POWERWAND XL 4Fr 10cm Extended Dwell Catheter Vascular Pathways Introducer Perfic Cath (Adapta) MAXITHERM PowerLoc Safety Infusion Set Correct Medication Labeling System Ansell Sandel Medical Solutions LLC Medication Labels-Sandel Specimen Handling System Ventilator, Emergency, Powered (resuscitator) PowerLoc MAX Power Injectable Infusion Set SafeStep Huber Needle Set Fluid Administration Set Merit Medical Systems, Inc. FAS Soft K-Bride; Soft K-Rette DirectFlow Fenestrated Catheters (Ambit Tunnerler) FMS VUO Tubing assemblies NovoTTF 100L System HOPE NEBULIZER STABLTRACH Corinth MedTech, Inc. FACE-IT SHIELD CT Transfer and related subassemblies (Merit) FAS Lines (Merit) Blade Disarmer Z-Tray Specimen Bowl Z-Cord and Tube Holder Change-A-Blade Z-Suture Bag Z-Friction Drape Z-Universal Holder Z-Scope Holder Histologics SoftBiopsy Tissue Collection and Transport System EntraCare Time Out Marker Sandel Safety Marker LiftLoc Safety Infusion Set PowerLoc Safety Infusion Set MiniLoc Safety Infusion Set Sandel Safety SCALPEL Miniloc Safety Infusion sets PowerLoc Max Safety Infusion Set Pacira Pharmaceuticals Inc. ambIT PreSet PCA Pump Aplicare Convenience Kits Aplicare Dressing Change Kit Creative Biotech Flow Meter CPAP Breathing Circuit and Mask CPAP Outset Medical, Inc. AMBIT Continuous Ambulatory Infusio Merit Disposal Depot Monojet Bone Marrow Biopsy Cardiopulmonary Bypass Blood Reserv ambIT PreSet Pump Fill Tube -720-000-0001 Tubing, Polyethylene J Tube Hook Tube MoBio Tube & Spin Filter Filter PowerLoc Safety Huber Merit Disposal Depot (BAG) MY8020-0006, MY8030-0006 & MY8060-0006 Part numbers: MY8003, MY8005, MY8010, MY8020, MY8030, MY8060, MY8003-0006, MY8005-0006, MY8010-0006, Texium Syringe Pacira Pharmaceuticals Inc. Tube Sets GEL MATRIX The Wand Micro Access Safety Introd Ansell Sandel Specimen Bowl Specimen Container Soft Endo Cervical Curette Histologics Soft-ECC Los Alamos Retractable Knife Futura Safety Scalpel ambIT Uni-Flo Fenestrated Catheter SDNA-1000 Saliva Collection Device Ventana Medical Pouch subassembly SwiftGrip BioPointe Pipette Tips BioPointe Bulk Pipette Tips Huber Needle infusion set RPS Adeno Detector, Catalogs: RPS-AD, RPS-DE, FSC-AD, NIC-AD Autosafe Advantage Safety Huber Infusion Set Autosafe-Reflex Safety Huber Infusion Set Sandel Safety Scalpel Time Out Scalpel Handle T Ring Digit tourniquet, T Ring Toe Tourniquet

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2009-05-11
JCY Catheter, Infusion General, Plastic Surgery Class 1 878.4200 2012-11-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-05-22
SHC Low Electric Field Generator For Pancreatic Cancer Treatment Unknown Class 3 N/A 2026-02-25
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2011-03-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-05-22
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2013-01-22
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2005-10-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-12-30
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-12-30
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2011-09-12
BTL Ventilator, Emergency, Powered (Resuscitator) Anesthesiology Class 2 868.5925 2012-09-04
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2012-09-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-11-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2009-05-11
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2019-03-05
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2011-01-28
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2014-09-25
HRX Arthroscope Orthopedic Class 2 888.1100 2013-08-29
QGZ Electrical Tumor Treatment Fields Unknown Class 3 N/A 2020-01-30
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2003-06-30
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2005-03-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-11-10
KQT Evacuator, Gastro-Urology Gastroenterology, Urology Class 2 876.4370 2021-11-10
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2021-11-10
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2005-10-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-01-22
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2012-01-04
OFD Catheter Introducer Kit Cardiovascular Class 2 870.1340 2017-06-30
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2017-11-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2007-10-05
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2011-11-10
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2018-03-27
FEN Device, Cystometric, Hydraulic Gastroenterology, Urology Class 2 876.1620 2015-08-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-10-05
FRN Pump, Infusion General Hospital Class 2 880.5725 2017-11-07
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2008-07-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-12-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-12-30
EXY Uroflowmeter Gastroenterology, Urology Class 2 876.1800 2018-08-07
GXH Device, Surgical, Cryogenic Neurology Class 2 882.4250 2022-04-29
MEA Pump, Infusion, Pca General Hospital Class 2 880.5725 2017-11-15
FRN Pump, Infusion General Hospital Class 2 880.5725 2017-11-15
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2009-04-20
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2011-03-24
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2009-05-11
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2021-11-29
FRN Pump, Infusion General Hospital Class 2 880.5725 2008-10-17
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2009-05-11
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2013-04-24
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2009-05-11
MEA Pump, Infusion, Pca General Hospital Class 2 880.5725 2017-11-17
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2012-09-17
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2012-10-12
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2017-10-05
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2011-03-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-10-17
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-05-05
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2009-05-11
FMF Syringe, Piston General Hospital Class 2 880.5860 2012-09-05
GXH Device, Surgical, Cryogenic Neurology Class 2 882.4250 2021-10-25
MRH Pump, Infusion, Ophthalmic General Hospital Class 2 880.5725 2011-03-25
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2003-06-30
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2009-05-05
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2012-01-30
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2012-04-19
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-06-06
MEA Pump, Infusion, Pca General Hospital Class 2 880.5725 2017-11-15
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2012-09-17
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2017-11-30
OYJ Dna Specimen Collection, Saliva Clinical Chemistry Class 2 862.1675 2020-11-25
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2014-05-28
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2010-06-04
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2012-08-01
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-03-15
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-11-10
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2020-11-10
GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33 Microbiology Class 1 866.3020 2013-05-31
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2011-03-18
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2011-03-18
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2012-03-15
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2013-08-05

Official Correspondent

Lamont Rohde

US Agent Details

Lamont Rohde Business: Amphenol Critical Medical Technologies, LLC Email: lamont.rohde@amphenol-cmt.com Phone: (602) 7503539

Related Public Records

Same Entity

Amphenol Critical Medical Technologies, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013596024 Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong, CN
3013500228 Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Tsimshatsui, Kowloon, HK

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009746061. Last updated year: 2026. Please use registration number 3009746061 when referencing this establishment in official correspondence.
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