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FDA 510(k)

Gemini Bonded Sterilization Wrap

K-Number: K152458 · 2016-06-01

ApplicantMedline Industries, Inc.
Decision Date2016-06-01
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Gemini Bonded Sterilization Wrap is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-06-01 under approval number K152458. 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 Bonded Sterilization Wrap?

Gemini Bonded Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2016-06-01. It is manufactured by Medline Industries, Inc.. The 510(k) number is K152458.

When was Gemini Bonded Sterilization Wrap approved by the FDA?

Gemini Bonded Sterilization Wrap received FDA 510(k) clearance on 2016-06-01, under approval number K152458.

What company makes Gemini Bonded Sterilization Wrap?

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

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

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

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Related Devices (Code: FRG)

K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, 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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