Visitec® 585012
by Beaver-Visitec International Inc
Visitec® 585012 is a Class I device made by Beaver-Visitec International Inc, cleared under FDA 510(k) K831901 on 12 Jul 1983 and listed in FDA GUDID since 1 Nov 2021 (UDI-DI 30886158101230), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30886158101230 | Date1 Nov 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK831901 | Date12 Jul 1983 | StatusActive |
Official records
- AccessGUDID record 30886158101230
- FDA 510(k) database K831901
Across registries
- FDA 510(k) K831901 decided 12 Jul 1983 Active
- FDA GUDID UDI-DI 30886158101230 listed 1 Nov 2021 Listed
Timeline
- Cleared FDA 510(k) K831901
- Listed FDA GUDID 30886158101230
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Visitec®
- Generic name
- Lacrimal intubation set
- Model / Ref / Catalog
- 585012
- Description
- DCR Set (Angled) [O'Donoghue] .90mm x 4.5cm (20G x 1 3/4in)
- Primary DI / UDI-DI
- 30886158101230
- 510(k) Number
- FDA product code
- HNL
- GMDN term
- Lacrimal intubation set
- Device class
- Class I
- Regulation number
- 886.4350
- GUDID distribution status
- In Commercial Distribution