FDA Registration
Active
🇺🇸 United States
BARD SHANNON LIMITED
Reg #: 3005636544
·
FEI: 3005636544
·
Expires 2026
Products
27
Proprietary Names
91
Establishment Types
1
Classifications
27
Registration Details
- Registration Name
- BARD SHANNON LIMITED
- Registration Number
- 3005636544
- FEI Number
- 3005636544
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- San Geronimo Industrial Park, Km. 76.7 Lot #1 Road #3 Bo. Rio Abajo
- City
- Humacao
- State
- PR
- ZIP
- 00791
- Country
- US
Owner / Operator
- Firm Name
- C. R. Bard, Inc.
- Operator Number
- 2212754
- Address
- 1 Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2012-07-10 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2012-07-10 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2010-05-11 |
| Surgical Film | OOD | Class 2 | General, Plastic Surgery | No | 2024-09-20 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2009-01-08 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2011-06-29 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2008-11-11 |
| Mesh, Surgical, Deployer | ORQ | Class 2 | General, Plastic Surgery | No | 2017-08-17 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2017-08-17 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2017-02-16 |
| Collagen Surgical Mesh Containing Drugs | PIJ | Class 2 | General, Plastic Surgery | No | 2017-02-16 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2017-02-16 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2008-11-11 |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | Class 2 | General, Plastic Surgery | No | 2014-03-28 |
| Tube, Gastro-Enterostomy | KGC | Class 2 | Gastroenterology, Urology | No | 2007-02-27 |
| Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | OTO | Class 2 | General, Plastic Surgery | No | 2011-04-13 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2007-02-27 |
| Mesh, Surgical, Deployment Balloon | OQL | Class 2 | General, Plastic Surgery | No | 2013-08-09 |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | Class 2 | General, Plastic Surgery | No | 2019-06-12 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-06-12 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2007-10-22 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2010-04-13 |
| Mesh, Surgical, Collagen, Diaphragmatic Hernia | OWV | Class 2 | General, Plastic Surgery | No | 2014-05-16 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2003-10-31 |
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | Class 2 | General, Plastic Surgery | No | 2018-07-13 |
| Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction | OWZ | Class 2 | General, Plastic Surgery | No | 2018-07-13 |
| Catheter, Coude | EZC | Class 2 | Gastroenterology, Urology | No | 2007-12-13 |
Proprietary Names
Ventrio
Ventralight
GalaFLEX 3DR
Vacora Vacuum Assisted Biopsy Sys
SorbaFix
PermaFix
UltraClip II US Tissue Marker
Marker (Ribbon)
UltraClip Dual Trigger Tissue
Echo 2
3DMax
XenMatrix
ONFLEX
UltraClip II Tissue Marker
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
Composix
Ventralex
UltraCor Twirl Breast Tissue Marker
Bard Button Gastrostomy Tube
Kugel
Alyte Y-Mesh Graft
Loc-Strap
Bard Male External Catheter (OTC)
Bard Infection Control Urinary
Needleless Sample Port Control Fit
Urine Collection Container -
bag/urinary drainage unit
Bard Deluxe Dispoz-A-Bag Drainage
Bag (Leg Bag)
Urinary Drainage Unit(urinary leg
Urotrack Plus (Model 220)
Bard Leg Bag Holder
w/ accessories)
Bed Bag
SureStep Foley Tray System Add-A-Foley Catheter (for Canada)
Bard Foley Catheterization Tray Uro-Prep Tray (for Canada)
SureStep Foley Tray System Complete Care Add-A-Foley Catheter (for Canada)
Bard Standard Latex Free Foley Tray without Catheter (for Canada)
Bard Male External Latex Disposable Catheter
Bardia Foley Catheter Insertion
w/o Catheter with Lubricant in
SureStep Intermittent Catheter Tray
Bard® Universal Catheterization Tray
Bardia Urethral Catheter Tray
5cc Balloon w/o Catheter
w/o Catheter
Foley Catheter Insertion Tray for
30cc Balloon w/o Catheter
Bard Foley Catheterization Tray
PerFix
Bard
Echo PS
GalaFLEX
Sepramesh
Bard Mesh
BARD
Bard Mesh Pre-Shaped
UltraClip Dual Trigger Breast
Tissue Marker (Wing and Coil)
UltraClip II MR Tissue Marker
GalaFLEX LITE
Phasix
PTFE Felt
Bard PTFE Felt Pledget
Low Porosity PTFE Felt
PTFE Felt (Thick)
Bard PTFE Braided Tape
Bard PTFE Thick Felt Pledget
OptiFix
CapSure
UltraClip II Tissue Marker Wing and
UltraClip II Tissue Marker Coil
DuaLok Breast Lesion Localization Wire
Ghiatas Beaded Breast Localization Wire
Align Urethral Support System
Bard Sauvage Filamentous Fabric
Align Introducers
Fast Track Tunneler Set
PelviSoft Introducers
InSnare Introducers
GalaFLEX 3D
Latex Foley Catheter & Drains
Bardex Councill Model Foley Catheter Percutaneous Nephrostomy
Bardex Nephrostomy Short Tip Councill Model Foley Catheter with Heyman Stylet
Lubricath Foley Catheter (offered in strips and trays)
Bardia Foley Catheter
Bard Lubricath Foley Catheter
Bard Urologist Tray
Bard Urologist Tray (for Canada)
Hohn
Broviac
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)