Customed 712057471070
Customed 712057471070 (9001070) 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 M20890010702), 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 | NumberM20890010702 | 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 M20890010702 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K953678
- Listed FDA GUDID M20890010702
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- Withdrawn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
- 712057471070, 9001070
- Primary DI / UDI-DI
- M20890010702
- 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
Similar devices
Other devices filed under FDA product code FRG (Wrap, Sterilization).
- Sterilization Pouch and Roll by Yichang Xinxin Paper Products Co., Ltd.
- Genesis Container System by Allegiance Healthcare Corp.
- Tyvek® Pouch/Roll with STERRAD® Chemical Indicator by Advanced Sterilization Products, Inc.
- G.E. STERILE, STANDARD BIOPSY TRAY by GE MEDICAL SYSTEMS, INC.
- NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION by Products For Medicine
- SUTURE REMOVAL TRAY by Cush Medical Products
- AESCULAP STERILCONTAINER SYSTEM by AESCULAP, INC.
- Tyvek Roll with CI for STERLINK Sterilizer by Plasmapp Co., Ltd.
- ECONOWRAP PAPER C.S.R. WRAP by Tower Products, Inc.
- STERITITE SEALED CONTAINERS MODEL SCO4Q by CASE MEDICAL INC