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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 a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2020-01-24 under approval 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. It is manufactured by Medline Industries, Inc.. The 510(k) number is K192641.

When was Gemini Titan Sterilization Wrap approved by the FDA?

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

What company makes Gemini Titan Sterilization Wrap?

Gemini Titan Sterilization Wrap is manufactured by Medline Industries, Inc..

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

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

Other Devices by Medline Industries, Inc.

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Related Devices (Code: FRG)

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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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