Osstem EXARO
by Osstem Implant Co., Ltd._Gasan Branch
Osstem EXARO is a Class II device made by Osstem Implant Co., Ltd._Gasan Branch, listed in FDA GUDID since 9 Aug 2016 (UDI-DI 08800000995014), 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 | Number08800000995014 | Date9 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 08800000995014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Osstem
- Generic name
- Portable basic diagnostic x-ray system, digital
- Model / reference
- EXARO
- Primary DI / UDI-DI
- 08800000995014
- FDA product code
- EHD
- GMDN term
- Portable basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
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