Ofix 10-002
by Icentia Inc
Ofix 10-002 is a Class I device made by Icentia Inc, listed in FDA GUDID since 26 Mar 2024 (UDI-DI 17540279100020), registry data as of 12 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number17540279100020 | Date26 Mar 2024 | StatusListed |
Official records
- AccessGUDID record 17540279100020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Ofix
- Generic name
- Cable/lead/sensor non-conductive skin-adherent patch, single-use
- Model / reference
- 10-002
- Primary DI / UDI-DI
- 17540279100020
- FDA product code
- KGX
- GMDN term
- Cable/lead/sensor non-conductive skin-adherent patch, single-use
- Device class
- Class I
- Regulation number
- 880.5240
- GUDID distribution status
- In Commercial Distribution
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