Gilras GRU-5000A
Gilras GRU-5000A is an ultrasound pachymeter (FDA Class II) made by U.S. Ophthalmic, L.L.C., listed in FDA GUDID since 17 Aug 2016 (UDI-DI 00851158007096), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851158007096 | Date17 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 00851158007096
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Gilras
- Generic name
- Ultrasound pachymeter
- Model / reference
- GRU-5000A
- Primary DI / UDI-DI
- 00851158007096
- FDA product code
- IYO, ITX
- GMDN term
- Ultrasound pachymeter
- Device class
- Class II
- Regulation number
- 892.1560, 892.1570
- GUDID distribution status
- In Commercial Distribution
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