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FDA 510(k)

ARJORAD STERILE WRAP

K-Number: K110954 · 2012-08-24

ApplicantArjo Wiggins Medical, Inc.
Decision Date2012-08-24
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARJORAD STERILE WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Arjo Wiggins Medical, Inc.. It received FDA 510(k) clearance on 2012-08-24 under 510(k) number K110954. 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 ARJORAD STERILE WRAP?

ARJORAD STERILE WRAP is a medical device that received FDA 510(k) clearance on 2012-08-24. The listed applicant is Arjo Wiggins Medical, Inc.. The 510(k) number is K110954.

When did ARJORAD STERILE WRAP receive FDA 510(k) clearance?

ARJORAD STERILE WRAP received FDA 510(k) clearance on 2012-08-24, under 510(k) number K110954.

Who is the listed applicant for ARJORAD STERILE WRAP?

The FDA 510(k) record lists Arjo Wiggins Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARJORAD STERILE WRAP?

The FDA product code for ARJORAD STERILE WRAP is FRG.

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Other records listing Arjo Wiggins Medical, Inc. 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.

K062100ARJOWRAP 47/100 AND 47/88K931202STERILIZATION WRAP-STERISHEET

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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