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FDA 510(k)

Gemini Titan Sterilization Wrap

K-Number: K192641 · 2020-01-24

ApplicantMedline Industries, Inc.
Decision Date2020-01-24
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Gemini Titan Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2020-01-24 under 510(k) number K192641. 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 Gemini Titan Sterilization Wrap?

Gemini Titan Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Medline Industries, Inc.. The 510(k) number is K192641.

When did Gemini Titan Sterilization Wrap receive FDA 510(k) clearance?

Gemini Titan Sterilization Wrap received FDA 510(k) clearance on 2020-01-24, under 510(k) number K192641.

Who is the listed applicant for Gemini Titan Sterilization Wrap?

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

What is the FDA product code for Gemini Titan Sterilization Wrap?

The FDA product code for Gemini Titan Sterilization Wrap is FRG.

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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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