Customed 712057470024

• FDA 510(k) K953678 decided 2 Oct 1995 Active
• FDA GUDID UDI-DI M2089000822 listed 23 Sep 2016 Listed

1. 2 Oct 1995 Cleared FDA 510(k) K953678
2. 23 Sep 2016 Listed FDA GUDID M2089000822

Trade name

Customed

Generic name

Sterilization packaging, single-use

Model / Ref / Catalog

712057470024, 900082

Primary DI / UDI-DI

M2089000822

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).

• PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator by Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti
• Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap by AHLSTROM NONWOVENS LLC
• STERILIZER WRAP by C. R. Bard, Inc.
• PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) by PRIMED MEDICAL PRODUCTS INC.
• Cardinal Health Sterilization Wrap by Cardinal Health 200, LLC
• AUTOCLAVE POUCHES&ROLLS/STEAM&GAS by E.M. Adams
• ORION CENTRAL LINE DRESSING CHANGE TRAY by Regulatory & Marketing Services, Inc.
• Gemini Bonded Sterilization Wrap by MEDLINE INDUSTRIES, INC.
• Vis-U-All Low Temperature Sterilization Pouch/Tubing by STERIS CORPORATION
• VIEW-PACK & MULTI POUCH by Sbw Medical Packaging, 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. →