Customed 712057470040
Customed 712057470040 (900084) is a Class II device made by Customed, Inc., cleared under FDA 510(k) K953678 on 2 Oct 1995 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI M2089000842), 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 | NumberM2089000842 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK953678 | Date2 Oct 1995 | StatusActive |
Official records
- FDA 510(k) database K953678
Across registries
- FDA 510(k) K953678 decided 2 Oct 1995 Active
- FDA GUDID UDI-DI M2089000842 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K953678
- Listed FDA GUDID M2089000842
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Customed
- Generic name
- Sterilization packaging, single-use
- Model / Ref / Catalog
- 712057470040, 900084
- Primary DI / UDI-DI
- M2089000842
- 510(k) Number
- FDA product code
- FRG
- GMDN term
- Sterilization packaging, single-use
- Device class
- Class II
- Regulation number
- 880.6850
- GUDID distribution status
- In Commercial Distribution
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