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FDA 510(k)

Cardinal Health Sterilization Wrap

K-Number: K161910 · 2017-04-20

ApplicantCardinal Health200, LLC
Decision Date2017-04-20
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Cardinal Health 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 2017-04-20 under 510(k) number K161910. 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 Cardinal Health Sterilization Wrap?

Cardinal Health Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K161910.

When did Cardinal Health Sterilization Wrap receive FDA 510(k) clearance?

Cardinal Health Sterilization Wrap received FDA 510(k) clearance on 2017-04-20, under 510(k) number K161910.

Who is the listed applicant for Cardinal Health 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 Cardinal Health Sterilization Wrap?

The FDA product code for Cardinal Health Sterilization Wrap is FRG.

Other records listing Cardinal Health200, LLC 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.

K241780Cardinal Health Nitrile Exam GlovesK230838Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument PocketsK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)K230028Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing AssemblyK201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloveK211390Nitrile Blue Powder-free Examination Glove

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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

View on FDA Database →

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

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