Eclipse PRP HC PRP2000-1.Intl
Eclipse PRP HC PRP2000-1.Intl is a Class II device made by Eclipse, Inc., listed under FDA premarket submission BK110035 and listed in FDA GUDID since 4 Oct 2018 (UDI-DI 00853602008093), active as of 22 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 | Number00853602008093 | Date4 Oct 2018 | StatusListed |
| United States | FDA 510(k) | NumberBK110035 | Date— | StatusActive |
Official records
- AccessGUDID record 00853602008093
Across registries
- FDA premarket submission BK110035 Active
- FDA GUDID UDI-DI 00853602008093 listed 4 Oct 2018 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eclipse PRP HC
- Generic name
- Haematological concentrate system
- Model / Ref / Catalog
- PRP2000-1.Intl
- Primary DI / UDI-DI
- 00853602008093
- FDA product code
- ORG
- GMDN term
- Haematological concentrate system
- Device class
- Class II
- Regulation number
- 864.9245
- GUDID distribution status
- In Commercial Distribution
- Size
- Weight — 123.8 GramDepth — 1.125 InchWidth — 6.938 InchHeight — 3.125 Inch
Similar devices
Other devices filed under FDA product code ORG (Platelet And Plasma Separator For Bone Graft Handling).