CarePoint Precision 202-2001
CarePoint Precision 202-2001 is a Class II device made by Allison Medical, Inc., cleared under FDA 510(k) K124037 on 12 Sep 2013 and listed in FDA GUDID since 29 Nov 2023 (UDI-DI 00786227220055), 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 | Number00786227220055 | Date29 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK124037 | Date12 Sep 2013 | StatusActive |
Official records
- AccessGUDID record 00786227220055
- FDA 510(k) database K124037
Across registries
- FDA 510(k) K124037 decided 12 Sep 2013 Active
- FDA GUDID UDI-DI 00786227220055 listed 29 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K124037
- Listed FDA GUDID 00786227220055
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CarePoint Precision
- Generic name
- Hypodermic needle, single-use
- Model / reference
- 202-2001
- Primary DI / UDI-DI
- 00786227220055
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Hypodermic needle, single-use
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
- Size
- Needle Gauge — 20 GaugeLength — 1 Inch
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