FDA 510(k)

DURA BLUE STERILIZATION WRAP

K-Number: K112211 · 2011-10-20

Decision Date2011-10-20

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DURA BLUE STERILIZATION WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2011-10-20 under 510(k) number K112211. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURA BLUE STERILIZATION WRAP?

DURA BLUE STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K112211.

When did DURA BLUE STERILIZATION WRAP receive FDA 510(k) clearance?

DURA BLUE STERILIZATION WRAP received FDA 510(k) clearance on 2011-10-20, under 510(k) number K112211.

Who is the listed applicant for DURA BLUE STERILIZATION WRAP?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURA BLUE STERILIZATION WRAP?

The FDA product code for DURA BLUE STERILIZATION WRAP is FRG.

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Related Devices (Code: FRG)

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLC K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.