Monoject SC4011X
Monoject SC4011X is a Class II device made by Cardinalhealth, cleared under FDA 510(k) K983187 on 10 Dec 1998 and listed in FDA GUDID since 14 Oct 2016 (UDI-DI 10884521021099), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521021099 | Date14 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK983187 | Date10 Dec 1998 | StatusActive |
Official records
- AccessGUDID record 10884521021099
- FDA 510(k) database K983187
Across registries
- FDA 510(k) K983187 decided 10 Dec 1998 Active
- FDA GUDID UDI-DI 10884521021099 listed 14 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K983187
- Listed FDA GUDID 10884521021099
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Monoject
- Generic name
- Bone marrow biopsy needle, single-use
- Model / Ref / Catalog
- SC4011X
- Primary DI / UDI-DI
- 10884521021099
- 510(k) Number
- FDA product code
- KNW
- GMDN term
- Bone marrow biopsy needle, single-use
- Device class
- Class II
- Regulation number
- 876.1075
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 4 Inch
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