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Gemini Sterilization Wrap

by Medline Industries, Inc. 3 variants

510(k) K150698

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150698 Date20 Nov 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FRG
Device class
Class II
Regulation
21 CFR Part 880.6850
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Gemini Sterilization Wrap is a sterilization wrap designed to protect instrument sets during sterilization processes. It is made from a durable, low-linting material that provides enhanced strength and high-level protection to ensure integrity throughout various sterilization methods.

The wrap is supplied in bulk packages of single sheets, with standard hospital practice using two sheets together. It is designed to be soft and easy to fold, with a strong material that resists tears and punctures from weighty instrument sets, rough edges, wire shelving, and stacked trays.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Gemini Sterilization Wrap used for?

    The Gemini Sterilization Wrap is designed to protect instrument sets during sterilization processes. It provides enhanced strength and high-level protection to ensure integrity throughout various sterilization methods.

  • How is the Gemini Sterilization Wrap supplied?

    The wrap is supplied in bulk packages of single sheets. Standard hospital practice typically involves using two sheets together for optimal protection during sterilization.

  • What are the key features of the Gemini Sterilization Wrap?

    The wrap is made from a durable, low-linting material that is soft and easy to fold. It features strong material that resists tears and punctures from weighty instrument sets, rough edges, wire shelving, and stacked trays.

  • Is the Gemini Sterilization Wrap single-use or reusable?

    The device data does not specify whether the Gemini Sterilization Wrap is single-use or reusable. For proper usage instructions, please consult the manufacturer's guidelines or product documentation.