Customed 712057470030

• FDA 510(k) K953678 decided 2 Oct 1995 Active
• FDA GUDID UDI-DI M2089000832 listed 23 Sep 2016 Listed

1. 2 Oct 1995 Cleared FDA 510(k) K953678
2. 23 Sep 2016 Listed FDA GUDID M2089000832

Trade name

Customed

Generic name

Sterilization packaging, single-use

Model / Ref / Catalog

712057470030, 900083

Primary DI / UDI-DI

M2089000832

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).

• SURGIPEEL SELF-SEAL PACKAGING SYSTEM by Surgicot, Inc.
• PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) by Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std
• Tyvek Sterilization Pouches with Chevron Seal by Andersen Sterilizers, Inc.
• SINGLE BASIN SET by Packaging Technologies, Inc.
• INSTRUTAINER by Intrumed, Inc.
• Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators by Safe Secure Packaging Co., Ltd.
• CENTRAL LINE DRESSING CHANGE TRAY by Clinical Resources, Inc.
• Steriking® LT-Blueline Pouches with Tyvek® by Wipak Oy
• Chex-All Sterilization Pouches and Tubes by Propper Manufacturing Co., Inc.
• APTIMAX™ 011077 by Advanced Sterilization Products, Inc.

• 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. →