FDA 510(k)

DURABLUE STERILIZATION WRAP

K-Number: K130927 · 2013-06-18

Decision Date2013-06-18

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DURABLUE 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 2013-06-18 under 510(k) number K130927. 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 DURABLUE STERILIZATION WRAP?

DURABLUE STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 2013-06-18. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K130927.

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

DURABLUE STERILIZATION WRAP received FDA 510(k) clearance on 2013-06-18, under 510(k) number K130927.

Who is the listed applicant for DURABLUE 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 DURABLUE STERILIZATION WRAP?

The FDA product code for DURABLUE 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.