SOFTEC HD PLI SOFHDPLI+5.5D and PLITIP1645 Kit
Active
PMA
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00844369002189 | Date1 Aug 2015 | StatusListed |
| United States | FDA PMAAPPR | NumberP090022 | Date12 Apr 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Softec Hd Pli
- Generic name
- Posterior-chamber intraocular lens, pseudophakic
- Model / Ref / Catalog
- SOFHDPLI+5.5D and PLITIP1645 Kit, SOFTEC HD PLI
- Primary DI / UDI-DI
- 00844369002189
- PMA number
- FDA product code
- HQL
- GMDN term
- Posterior-chamber intraocular lens, pseudophakic
- Device class
- Class III
- Regulation number
- 886.3600
- GUDID distribution status
- In Commercial Distribution
Other devices from Lenstec Barbados Inc
Properties
Other properties (8)
- Sterilise before use: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Manufacturing date: No