Tropocells 06212SC
Tropocells 06212SC, a haematological concentrate system preparation kit (FDA Class II; FDA product code ORG, Platelet And Plasma Separator For Bone Graft Handling) made by Estar Technologies Ltd, was listed under FDA premarket submission BK110035 and listed in FDA GUDID on 18 Oct 2016 (UDI-DI 17290015874202); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
510(k) BK110035
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number17290015874202 | Date18 Oct 2016 | StatusListed |
| United States | FDA 510(k) | NumberBK110035 | Date— | StatusActive |
Official records
- AccessGUDID record 17290015874202
Across registries
- FDA premarket submission BK110035 Active
- FDA GUDID UDI-DI 17290015874202 listed 18 Oct 2016 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tropocells
- Generic name
- Haematological concentrate system preparation kit, platelet concentration
- Model / Ref / Catalog
- 06212SC
- Primary DI / UDI-DI
- 17290015874202
- FDA product code
- ORG
- GMDN term
- Haematological concentrate system preparation kit, platelet concentration
- Device class
- Class II
- Regulation number
- 864.9245
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code ORG (Platelet And Plasma Separator For Bone Graft Handling).