McKesson 2261
by Mckesson Medical-Surgical Inc.
McKesson 2261 is a sharps container (FDA Class II; FDA product code FMI, Needle, Hypodermic, Single Lumen) made by Mckesson Medical-Surgical Inc., cleared under FDA 510(k) K970383 on 3 Jul 1997 and listed in FDA GUDID since 9 Dec 2016 (UDI-DI 10612479209364), 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 | Number10612479209364 | Date9 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK970383 | Date3 Jul 1997 | StatusActive |
Official records
- AccessGUDID record 10612479209364
- FDA 510(k) database K970383
Across registries
- FDA 510(k) K970383 decided 3 Jul 1997 Active
- FDA GUDID UDI-DI 10612479209364 listed 9 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K970383
- Listed FDA GUDID 10612479209364
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- McKesson
- Generic name
- Sharps container
- Model / reference
- 2261
- Primary DI / UDI-DI
- 10612479209364
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Sharps container
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
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- MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE by BECTON, DICKINSON & CO.
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