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FDA 510(k)

DURABLUE STERILIZATION WRAP

K-Number: K132060 · 2013-12-13

ApplicantCardinal Health-Medical Products and Services
Decision Date2013-12-13
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 Health-Medical Products and Services. It received FDA 510(k) clearance on 2013-12-13 under 510(k) number K132060. 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 2013-12-13. The listed applicant is Cardinal Health-Medical Products and Services. The 510(k) number is K132060.

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

DURABLUE STERILIZATION WRAP received FDA 510(k) clearance on 2013-12-13, under 510(k) number K132060.

Who is the listed applicant for DURABLUE STERILIZATION WRAP?

The FDA 510(k) record lists Cardinal Health-Medical Products and Services 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.

Related Clinical Trials

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Other records listing Cardinal Health-Medical Products and Services as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123289DURABLUE STERILIZATION WRAPK120542CARDINAL HEALTH DURABLUE STERILIZATION WRAPK113707STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATINGK111868STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATINGK983962ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES

Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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, LLCK253454HALYARD* 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

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

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