Contract sterilizerBaxter Healthcare of Puerto Rico LLC (Aibonito, PR)Puerto RicoEar, nose and throatGeneral hospitalGastroenterology and urologyGeneral and plastic surgeryObstetrics and gynecologyOrthopedicMicrobiologyClass IClass II
Baxter Healthcare of Puerto Rico LLC
Contract sterilizer · Aibonito, PR
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2649614 (openFDA record; or search FDA's registration database)
- FEI number
- 2649614
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract sterilizer
- Owner or operator
- BAXTER HEALTHCARE CORPORATION (FDA owner/operator no. 1417572)
- Registered address
- RD. 721, KM. 0.3, Aibonito, PR 00705
- Contract listings
- 30 device listings, 29 product codes, first listed Dec 1, 1988
- 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 |
|---|---|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | Class I | Ear, nose and throat | Contract sterilization | Nov 24, 2015 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Class II | Ear, nose and throat | Contract sterilization | Nov 24, 2015 |
| FQH | Lavage, Jet | Class II | General hospital | Contract sterilization | Nov 24, 2015 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Nov 28, 2012 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class II | General hospital | Contract sterilization | Nov 28, 2012 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | Class I | General and plastic surgery | Contract sterilization | Nov 24, 2015 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Nov 28, 2012 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract sterilization | Nov 24, 2015 |
| GFF | Bur, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Nov 24, 2015 |
| HET | Laparoscope, Gynecologic (And Accessories) | Class II | Obstetrics and gynecology | Contract sterilization | Nov 28, 2012 |
| HRX | Arthroscope | Class II | Orthopedic | Contract sterilization | Nov 24, 2015 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract sterilization | Jan 3, 1990 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Nov 24, 2015 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | Nov 28, 2012 |
| JDZ | Mixer, Cement, For Clinical Use | Class I | Orthopedic | Contract sterilization | Nov 28, 2012 |
| JTW | System, Transport, Aerobic | Class I | Microbiology | Contract sterilization | Nov 28, 2023 |
| JTX | Transport Systems, Anaerobic | Class I | Microbiology | Contract sterilization | Nov 28, 2023 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | General and plastic surgery | Contract sterilization | Dec 1, 1988 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract sterilization | Nov 24, 2015 |
| KQT | Evacuator, Gastro-Urology | Class II | Gastroenterology and urology | Contract sterilization | Nov 28, 2012 |
| LJH | System, Irrigation, Urological | Class II | Gastroenterology and urology | Contract sterilization | Nov 25, 2015 |
| LOD | Bone Cement | Class II | Orthopedic | Contract sterilization | Nov 24, 2015 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract sterilization | Nov 24, 2015 |
| LZN | Cement Obturator | Class II | General and plastic surgery | Contract sterilization | Nov 24, 2015 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Nov 24, 2015 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract sterilization | Nov 24, 2015 |
| NDN | Cement, Bone, Vertebroplasty | Class II | Orthopedic | Contract sterilization | Nov 24, 2015 |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | Class I | Orthopedic | Contract sterilization | Nov 24, 2015 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | Class I | Orthopedic | Contract sterilization | Nov 28, 2023 |