Estcarbon PA992
Estcarbon PA992 is a Class I device made by Erismet OU, listed in FDA GUDID since 9 Sep 2024 (UDI-DI 04744946012418), 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 | Number04744946012418 | Date9 Sep 2024 | StatusListed |
Official records
- AccessGUDID record 04744946012418
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Estcarbon
- Generic name
- Orthotic insole, prefabricated, non-antimicrobial
- Model / reference
- PA992
- Primary DI / UDI-DI
- 04744946012418
- FDA product code
- KYS
- GMDN term
- Orthotic insole, prefabricated, non-antimicrobial
- Device class
- Class I
- Regulation number
- 880.6280
- GUDID distribution status
- In Commercial Distribution
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