COOK MEDICAL LLC

FDA Device Registration & Listing · Bloomington, IN, US · Registration 3005580113

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
3005580113
FEI Number
3005580113
Entity Name
COOK MEDICAL LLC
City/State/Country
Bloomington, IN, US
Establishment Address
400 DANIELS WAY, Bloomington, IN 47404, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
COOK MEDICAL (Owner Number: 9090900)
Owner / Operator Contact Address
400 DANIELS WAY, --, Bloomington, IN 47404, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Fixed-Core Wire Guides Sydney IVF Culture Oil Semi-Automatic Needle Automatic Biopsy Needle BAM Automatic Biopsy Needle Semi-Automatic Needle BIM Omnitech Electrodes Peel-Away Sheath Introducer QL Inflation Device Transmyometrial Embryo Transfer Set Sentrus Insufflation Tubing Sentrus Hybrid Irrigation Tubing Sentrus Irrigation Tubing Sentrus Insufflation Tubing with CO2 Connector Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach Cook Celect Platinum Vena Cava Filter set for Jugular Vein Approach Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Quanta System Surgical Laser Fibers EchoTip Ingight Portosystemic Pressure Gradient Measurement System Entuit Thrive Balloon Retention Gastrostomy Feeding Tube Sydney IVF PVP Zilver 635 Biliary Self Expanding Metal Stent Syfonix Suction Ureteral Access Sheath Disposable Ureteral Access Sheath Peel-Away Introducer Set Peel-Away Introducer Sheath Set Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath Flexor® Ureteral Access Sheath Pigtail Drainage Catheter Needle Set Percutaneous Nephrostomy Set Nephrostomy Pigtail Drainage Catheter Multipurpose Drainage Catheters and Sets EchoTip® ClearCore™ EUS Biopsy Needle EchoTip AcuCore™ EUS Biopsy Needle Advance Serenity 18 Hydrophilic PTA Balloon Catheter Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter Stent Introducer Set Solus(R) Double Pigtail Stent with Introducer Oasis-One Action Stent Introduction system(R) ST-2 Soehendra® Tannenbaum® Biliary Stent Cotton-Leung Biliary Stent Set Fusion Oasis One Action Stent Introduction System Pushing Catheter Guiding Catheter Oasis-one action stent introduction system® with Pre-loaded Cotton-Leung® Biliary Stent Cotton-Huibregtse(R) Biliary Stent Cotton-Leung® (Amsterdam) Biliary Stent Set Cotton-Huibregtse® Biliary Stent Set Fusion® Pushing Catheter Cotton-Leung® Biliary Stent Fusion® Oasis® – One Action Stent Introducer System Solus Biliary Stent and Introducer Set Cotton Leung Oasis® Stent Introduction System Zimmon(R) Biliary stent Huibregtse Guiding Catheter Zimmon® Biliary Stent Set Oasis® One Action Stent Introduction System with Pre-Loaded ST-2 Tannenbaum® Biliary Stent COOK Ultra Quiet Vacuum Pump & Regulator Sydney IVF Sperm Solutions MPIS Zenith Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent) Ovum Pick-up Aspiration Needle Wayne Pneumothorax Catheter Set and Tray Disposable Polypectomy Cold Snare Zilver® VenaTM Venous Self-Expanding Stent Lunderquist® Extra Stiff Wire Guide DC Wire Guides Adv Serenity 014 COOK Mini-Incubator Evolution® Esophageal Stent System-Partially Covered Sentrus Endoscopic Bedside Kit Sentrus Cleaning Sponge Sydney IVF Sperm Cryopreservation Buffer Flexor Guiding Sheath Flexor Introducer Ascend™ Single-Use Flexible Cysto-Nephroscope HD, Standard Ascend™ Single-Use Flexible Cysto-Nephroscope HD, Reverse Ascend™ Single-Use Flexible Cysto-Nephroscope Esophageal TTS Stent DC Wire Guides Lunderquist® Extra Stiff Wire Guide Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Evolution® Esophageal Stent System- Fully Covered Evolution® Esophageal Controlled-Release Stent -Fully Covered Mandril Wire Guide BIGopsy ng forceps BIGopsy® Backloading Biopsy Forceps EndoTNeedle Resonance® Stent Introducer Resonance Stent Set Resonance Positioner Resonance® Metallic Ureteral Stent and Introducer Compass Cast and MAP Ascend™ Single-Use Flexible Ureteroscope, Standard Endoscopic Video Image Processor HD Ascend™ Single-Use Flexible Ureteroscope, Reverse Niti-S Biliary Stent Evolution® Duodenal Controlled-Release Stent - Uncovered Evolution® Duodenal Stent System- Uncovered iCast covered stent system Volante Steerable Guiding Sheath Ascend Single-Use Flexible Ureteroscope EchoTip® ClearCore™ EUS Biopsy Needle Quanta System Surgical Laser Fibers Sydney IVF Hyaluronidase (bovine only - not ovine) Colon Decompression Set ECHOTIP® ULTRA Celiac Plexus Neurolysis Needle Sydney IVF Culture Oil Nasal Pancreatic Drainage Set EchoTip® Ultra High Definition Ultrasound Access Needle Geenen® Pancreatic Stent Set Guiding Catheter Geenen Sofflex Pancreatic Stent Pushing Catheter Zimmon® Pancreatic Stent Set Geenen® Pancreatic Stent Zimmon® Pancreatic Stent Johlin Pancreatic Wedge Stent Sydney IVF PVP Nasal Biliary Drainage Catheter Liguory Nasal Biliary Drainage Set Liguory Nasal Biliary Drainage Set Radiopaque Tip Leung Nasal Biliary Drainage Catheter Nagaraja Nasal Biliary Drainage Set Liguory Nasal Biliary Drainage Catheter Leung Nasal Biliary Drainage Set Nasal Biliary Drainage Set Nagaraja Nasal Biliary Drainage Catheter Flexgrip Zenith Alpha™ Thoracic Endovascular Graft – Proximal Component Zenith Alpha™ Thoracic Endovascular Graft – Distal Extension Zenith Alpha™ Thoracic Endovascular Graft – Distal Component Zenith Alpha™ Thoracic Endovascular Graft – Proximal Tapered Component Zenith Alpha® 2 Thoracic Endovascular Graft – Proximal Component Zenith Alpha® 2 Thoracic Endovascular Graft – Proximal Tapered Component Zenith Alpha® 2 Thoracic Endovascular Graft – Distal Extension Zenith Alpha® 2 Thoracic Endovascular Graft – Distal Component Sydney IVF Cryopreservation Kit Sydney IVF Thawing Kit Zilver 635 Vascular Self-Expanding Stent Zilver 635® Vascular Stent Zilver 518 Vascular Self-Expanding Stent Zilver 518® Vascular Stent Endovascular Dilator Dilator Sets Nylon Dilator Zilver® PTX® Drug-Eluting Peripheral Stent ShortShot Saeed Hemorrhoidal Ligator with Triview Anoscope ShortShot® Saeed Hemorrhoidial Multi-Band Ligator with TriView® Anoscope Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach Cook Celect Platinum Vena Cava Filter set for Jugular Vein Appraoch Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach COOK Sydney IVF Blastocyst Vitrification Kit COOK Sydney IVF Blastocyst Warming Kit Sentrus Bite Block Sydney IVF Egg/Embryo Solutions Zilver 635® Biliary Stent Zilver 518® Biliary Stent Zilver 518 Biliary Self-Expanding Stent ProFusion Therapeutic Infusion Needle Coaxial Interventional Needle COOK Test Tube Heater Disposable Stone Collector Sydney IVF Embryo Biopsy Medium Niti-S Esophageal Stent Double Lumen Ovum Aspiration Needle Sentrus Dual-End Cleaning Brush Sentrus Endoscope Transport Bag Duette® Multi-Band Mucosectomy Duette® Multi-Band Mucosectomy Device Sentrus Suction Tubing COOK IVF Sperm Solutions Sydney IVF Blastocyst Freeze/Thaw Kit Towako Transmyometrial Embryo Transfer Set Sydney IVF Embryo Biopsy Medium Sydney IVF Blastocyst Cryopreservation Kit Sydney IVF Blastocyst Thawing Kit Otrieva Tapered Ovum Aspiration Needle COOK IVF Egg/Embryo Solutions ENFit connector Feeding Tube with ENFit Connection

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-06-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2025-12-11
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2023-01-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-08-11
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-08-11
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2023-01-19
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2023-01-19
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2019-07-25
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2025-09-01
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2024-07-05
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-11-09
QIJ Endoscopic Transhepatic Venous Access Needle Gastroenterology, Urology Class 2 876.1050 2019-12-06
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2023-01-06
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2019-07-25
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-12-10
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-08-11
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-08-11
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-05-20
GBO Catheter, Nephrostomy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2023-11-13
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-11-13
LJE Catheter, Nephrostomy Unknown Class U N/A 2023-11-13
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2025-01-16
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-01-16
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-01-21
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2022-03-07
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2019-07-25
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-06-12
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2019-07-25
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2019-07-25
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2025-02-18
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2024-09-17
QAN Stent, Iliac Vein Unknown Class 3 N/A 2020-11-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2019-07-25
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-01-06
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2019-07-25
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2019-07-25
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2025-09-01
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-06-07
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-01-13
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2023-01-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2022-06-17
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2019-07-25
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2019-07-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-09-25
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2019-07-26
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-01-06
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2019-07-25
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2023-01-06
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2023-01-06
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-01-13
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-01-06
MUM Stent, Metallic, Expandable, Duodenal General, Plastic Surgery Class 2 878.3610 2019-07-25
MQR Stent, Colonic, Metallic, Expandable General, Plastic Surgery Class 2 878.3610 2019-07-25
PRL Iliac Covered Stent, Arterial Unknown Class 3 N/A 2024-04-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2026-04-08
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-01-03
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2025-01-16
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-11-09
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation Gastroenterology, Urology Class 2 876.5980 2020-03-13
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2019-07-25
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2019-10-31
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2019-07-25
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2026-02-18
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2019-07-25
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2024-01-03
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2019-07-25
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
NIO Stent, Iliac Unknown Class 3 N/A 2019-07-25
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2019-07-25
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-11-13
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2023-11-13
NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown Class 3 N/A 2019-07-25
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2019-07-25
FER Anoscope And Accessories Gastroenterology, Urology Class 2 876.1500 2019-07-25
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2019-07-25
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
MNK Endoscopic Bite Block Gastroenterology, Urology Class 1 876.1500 2025-09-01
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2019-07-25
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2023-01-06
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2019-07-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-11-14
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2025-12-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2023-01-06
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2019-07-25
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2019-07-26
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2019-07-25
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2025-09-01
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2019-09-04
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2019-07-25
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-25
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2023-01-06
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2023-01-06

Official Correspondent

Ed Sutkowski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COOK MEDICAL
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31
K992169 Advanced Cardiovascular Systems, Inc. ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE 1999-10-28
K012534 Advanced Cardiovascular Systems, Inc. HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2026 Cook Medical Incorporated 3
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40-36-217-W ZTA2-PT-42-38-173 ZTA2-PT-42-38-173-W ZTA2-PT-42-38-225 ZTA2-PT-42-38-225-W ZTA2-PT-44-40-179 ZTA2-PT-44-40-179-W ZTA2-PT-44-40-233-W ZTA2-PT-46-42-179 ZTA2-PT-46-42-179-W ZTA2-PT-46-42-233 ZTA2-PT-46-42-233-W ZTA2-P-46-233 ZTA2-PT-44-40-233 ZTA2-P-40-217 ZTA2-P-40-117 ZTA2-P-40-167-DEMO ZTA2-P-44-152-W ZTA2-P-40-142 ZTA2-P-44-152 ZTA2-P-40-142-W
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0027-2024 Bard Peripheral Vascular Inc 2
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013 Remington Medical Inc. 2
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005580113. Last updated year: 2026. Please use registration number 3005580113 when referencing this establishment in official correspondence.
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