Contract manufacturerBARD SHANNON LIMITED (Humacao, PR)Puerto RicoCardiovascularGastroenterology and urologyGeneral and plastic surgeryRadiologyGeneral hospitalClass IIClass I
BARD SHANNON LIMITED
Contract manufacturer ยท Humacao, PR
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3005636544 (openFDA record; or search FDA's registration database)
- FEI number
- 3005636544
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- C. R. Bard, Inc. (FDA owner/operator no. 2212754)
- Registered address
- San Geronimo Industrial Park, Km. 76.7 Lot #1 Road #3 Bo. Rio Abajo, Humacao, PR 00791
- Contract listings
- 56 device listings, 26 product codes, first listed Mar 18, 1994
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | Class II | Cardiovascular | Contract manufacturing | Mar 14, 2007 |
| EZC | Catheter, Coude | Class II | Gastroenterology and urology | Contract manufacturing | Dec 13, 2007 |
| FTL | Mesh, Surgical, Polymeric | Class II | General and plastic surgery | Contract manufacturing | Feb 27, 2007 |
| FTM | Mesh, Surgical | Class II | General and plastic surgery | Contract manufacturing | May 16, 2014 |
| FZP | Clip, Implantable | Class II | General and plastic surgery | Contract manufacturing | Nov 11, 2008 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Aug 9, 2013 |
| GDW | Staple, Implantable | Class II | General and plastic surgery | Contract manufacturing | Nov 11, 2008 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract manufacturing | Jul 10, 2012 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Class II | Radiology | Contract manufacturing | Jul 10, 2012 |
| KGC | Tube, Gastro-Enterostomy | Class II | Gastroenterology and urology | Contract manufacturing | Feb 27, 2007 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract manufacturing | Jan 8, 2009 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Class II | Gastroenterology and urology | Contract manufacturing | Feb 27, 2007 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class II | General hospital | Contract manufacturing | Oct 22, 2007 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Mar 18, 1994 |
| NEU | Marker, Radiographic, Implantable | Class II | General and plastic surgery | Contract manufacturing | Nov 11, 2008 |
| OOD | Surgical Film | Class II | General and plastic surgery | Contract manufacturing | Nov 15, 2016 |
| OQL | Mesh, Surgical, Deployment Balloon | Class II | General and plastic surgery | Contract manufacturing | Aug 9, 2013 |
| ORQ | Mesh, Surgical, Deployer | Class II | General and plastic surgery | Contract manufacturing | Aug 17, 2017 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | Class II | General and plastic surgery | Contract manufacturing | Dec 10, 2007 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | Class II | General and plastic surgery | Contract manufacturing | Apr 13, 2011 |
| OWT | Mesh, Surgical, Absorbable, Abdominal Hernia | Class II | General and plastic surgery | Contract manufacturing | Jul 13, 2018 |
| OWV | Mesh, Surgical, Collagen, Diaphragmatic Hernia | Class II | General and plastic surgery | Contract manufacturing | May 16, 2014 |
| OWZ | Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction | Class II | General and plastic surgery | Contract manufacturing | Jul 13, 2018 |
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | Class II | General and plastic surgery | Contract manufacturing | Jul 13, 2018 |
| OXH | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | Class II | General and plastic surgery | Contract manufacturing | May 16, 2014 |
| PIJ | Collagen Surgical Mesh Containing Drugs | Class II | General and plastic surgery | Contract manufacturing | Aug 4, 2015 |