Customed 712057470054

• FDA 510(k) K953678 decided 2 Oct 1995 Active
• FDA GUDID UDI-DI M2089000862 listed 23 Sep 2016 Listed

1. 2 Oct 1995 Cleared FDA 510(k) K953678
2. 23 Sep 2016 Listed FDA GUDID M2089000862

Trade name

Customed

Generic name

Sterilization packaging, single-use

Model / Ref / Catalog

712057470054, 900086

Primary DI / UDI-DI

M2089000862

510(k) Number

K953678 ↗

FDA product code

FRG

GMDN term

Sterilization packaging, single-use

Device class

Class II

Regulation number

880.6850

GUDID distribution status

In Commercial Distribution

Category: Sterilization packaging, single-use

Other devices filed under FDA product code FRG (Wrap, Sterilization).

• Sterilization Pouch/Roll Made with Tyvek by Sigma Medical Supplies Corp.
• STERILIZATION POUCH WITH INDICATORS by Winner Industries (Shenzhen) Co., Ltd.
• STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS by CASE MEDICAL INC
• Sterisheet Sterilization Wrap by Andersen Sterilizers, Inc.
• CARAPACE DEBRIDEMENT KITS by Carapace, Inc.
• BIOPSY TRAY by Medcare Medical Group, Inc.
• INCISION/DRAINAGE TRAY by Cush Medical Products
• PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator by Pms Tibbi Cihazlar Teknolojisi San VE Tic AS
• SELF SEAL STERILIZATION POUCH by Shanghai Jianzhong Medical Packaging Co., Ltd.
• SUTURE REMOVAL KIT by Westmark Hospital Supplies

• Sterile Suture Removal Kit

  Class I

  FDA 510(k) K925015 Active Cleared 7 Jun 1993

• Customed 712057831816

  Class II

  FDA 510(k) K092338 Active Cleared 27 May 2011 GUDID on market

• Customed 712057102985

  Class I

  GUDID on market

• Customed 712057462213

  Class II

  FDA 510(k) K081633 Active Cleared 11 Aug 2008 GUDID on market

See all devices from Customed, Inc. →