MR Phaco PH85011
MR Phaco PH85011 is a Class I device made by Crestpoint Management Ltd., listed in FDA GUDID since 30 May 2025 (UDI-DI G412PH850110), registry data as of 23 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 | NumberG412PH850110 | Date30 May 2025 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- MR Phaco
- Generic name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
- Model / reference
- PH85011
- Primary DI / UDI-DI
- G412PH850110
- FDA product code
- HMX
- GMDN term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
- Device class
- Class I
- Regulation number
- 886.4350
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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