Insulin Syringe 6943
Insulin Syringe 6943 is a Class II device made by Dynarex Corp., cleared under FDA 510(k) K112057 on 14 Dec 2011 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00616784694320), 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 | Number00616784694320 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112057 | Date14 Dec 2011 | StatusActive |
Official records
- AccessGUDID record 00616784694320
- FDA 510(k) database K112057
Across registries
- FDA 510(k) K112057 decided 14 Dec 2011 Active
- FDA GUDID UDI-DI 00616784694320 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K112057
- Listed FDA GUDID 00616784694320
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Insulin Syringe
- Generic name
- Insulin syringe/needle, basic
- Model / reference
- 6943
- Primary DI / UDI-DI
- 00616784694320
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- Insulin syringe/needle, basic
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
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