Contract sterilizerIntuitive Solutions (Carrollton, TX)TexasGastroenterology and urologyObstetrics and gynecologyClass II
Intuitive Solutions
Contract sterilizer ยท Carrollton, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3042953929 (openFDA record; or search FDA's registration database)
- FEI number
- 3042953929
- Registered for
- FDA registration year 2027
- Establishment types
- Contract sterilizer
- Owner or operator
- Intuitive Surgical, Inc. (FDA owner/operator no. 9028901)
- Registered address
- 3000 Kellway Dr Ste 1000, Carrollton, TX 75006
- Contract listings
- 8 device listings, 3 product codes, first listed Apr 3, 2014
- 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 |
|---|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Apr 30, 2015 |
| HIF | Insufflator, Laparoscopic | Class II | Obstetrics and gynecology | Contract sterilization | Mar 15, 2024 |
| NAY | System, Surgical, Computer Controlled Instrument | Class II | Gastroenterology and urology | Contract sterilization | Apr 3, 2014 |