89129
89129 is a Class II device made by Stryker Leibinger, cleared under FDA 510(k) K972034 on 20 Jan 1998 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 07613252085577), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07613252085577 | Date24 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK972034 | Date20 Jan 1998 | StatusActive |
Official records
- AccessGUDID record 07613252085577
- FDA 510(k) database K972034
Across registries
- FDA 510(k) K972034 decided 20 Jan 1998 Active
- FDA GUDID UDI-DI 07613252085577 listed 24 Aug 2016 Listed
Recalls
-
- Terminated Z-2302-2008
The Ocular Conformers were distributed with an expired expiration date.
Timeline
- Cleared FDA 510(k) K972034
- Recall initiated FDA recalls Z-2302-2008
- Listed FDA GUDID 07613252085577
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Ophthalmic conformer
- Model / Ref / Catalog
- 89129
- Primary DI / UDI-DI
- 07613252085577
- 510(k) Number
- FDA product code
- HQN
- GMDN term
- Ophthalmic conformer
- Device class
- Class II
- Regulation number
- 886.3130
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 26.0 MillimeterHeight — 22.0 Millimeter
Similar devices
Other devices filed under FDA product code HQN (CONFORMER, OPHTHALMIC).
- OCULAR CONFORMER by Southwest Artificial Eyes, Inc.
- KOLBERG OPHTHALMIC CONFORMER by Kolberg Ocular Products, Inc.
- STERILE/SINGLE USE OPHTHALMIC CONFORMERS by Storz Instrument Co.
- MOLDEYE by Robert B. Scott Ocularists of Florida, Inc.
- MEDPOR OCULAR CONFORMER by Porex Surgical, Inc.
- STERILE/SINGLE USE SYMBLEPHARON RING by Storz Instrument Co.