Contract manufacturerCovidien (Ponce, PR)Puerto RicoGastroenterology and urologyGeneral and plastic surgeryGeneral hospitalObstetrics and gynecologyClass IIClass I
Covidien
Contract manufacturer ยท Ponce, PR
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2647580 (openFDA record; or search FDA's registration database)
- FEI number
- 2647580
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer
- Owner or operator
- Covidien llc (FDA owner/operator no. 1282497)
- Registered address
- BUILDING 911-67, SABANETAS INDUSTRIAL PARK, Ponce, PR 00731
- Contract listings
- 32 device listings, 16 product codes, first listed Jul 11, 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 |
|---|---|---|---|---|---|
| FBQ | Trocar, Gastro-Urology | Class II | Gastroenterology and urology | Contract manufacturing | Apr 24, 2007 |
| FEB | Accessories, Cleaning, For Endoscope | Class II | Gastroenterology and urology | Contract manufacturing | Apr 24, 2007 |
| FHM | Apparatus, Suturing, Stomach And Intestinal | Class I | General and plastic surgery | Contract manufacturing | Apr 24, 2007 |
| FHO | Pneumoperitoneum Needle | Class II | Gastroenterology and urology | Contract manufacturing | Jul 11, 1994 |
| FZP | Clip, Implantable | Class II | General and plastic surgery | Contract manufacturing | Dec 4, 1997 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Mar 20, 1997 |
| GAG | Stapler, Surgical | Class II | General hospital | Contract manufacturing | Dec 4, 1997 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Dec 4, 1997 |
| GDH | Gouge, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Apr 24, 2007 |
| GDO | Applier, Surgical, Clip | Class I | General and plastic surgery | Contract manufacturing | Dec 4, 1997 |
| GDW | Staple, Implantable | Class II | General and plastic surgery | Contract manufacturing | Dec 4, 1997 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Dec 4, 1997 |
| GET | Motor, Surgical Instrument, Pneumatic Powered | Class I | General and plastic surgery | Contract manufacturing | Apr 24, 2007 |
| HDA | Forceps, Obstetrical | Class II | Obstetrics and gynecology | Contract manufacturing | Apr 24, 2007 |
| HET | Laparoscope, Gynecologic (And Accessories) | Class II | Obstetrics and gynecology | Contract manufacturing | Dec 4, 1997 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | Class II | Gastroenterology and urology | Contract manufacturing | Dec 4, 1997 |