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Durablue Sterilization Wrap

by Cardinal Health, Medical Products and Services 2 variants

510(k) K132060

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 NumberK132060 Date13 Dec 2013ClearedStatusActive

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  • Withdrawn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
FDA applicant
Cardinal Health-Medical Products and Services
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The Durablue Sterilization Wrap is a sterilization wrap used for sterilization purposes. It is designed to provide a durable and reliable way to protect medical supplies during the sterilization process.

The Durablue Sterilization Wrap is supplied in various sizes, including 36x36in and 54x54in. It is a single-use product and is intended for use in a hospital setting. The device has received FDA 510K authorization and is classified under product code FRG.

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