Eclipse PRP, Tropocells 26754E
Eclipse PRP, Tropocells 26754E is 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, listed under FDA premarket submission BK110035 and listed in FDA GUDID since 18 Oct 2016 (UDI-DI 07290015874328), active 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 | Number07290015874328 | Date18 Oct 2016 | StatusListed |
| United States | FDA 510(k) | NumberBK110035 | Date— | StatusActive |
Official records
- AccessGUDID record 07290015874328
Across registries
- FDA premarket submission BK110035 Active
- FDA GUDID UDI-DI 07290015874328 listed 18 Oct 2016 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eclipse PRP, Tropocells
- Generic name
- Haematological concentrate system preparation kit, platelet concentration
- Model / Ref / Catalog
- 26754E
- Primary DI / UDI-DI
- 07290015874328
- FDA product code
- ORG
- GMDN term
- Haematological concentrate system preparation kit, platelet concentration
- Device class
- Class II
- Regulation number
- 864.9245
- GUDID distribution status
- In Commercial Distribution