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REXAM Fracture Resistant Pouch

by Rexam Medical Packaging, Inc.

510(k) K973440

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 NumberK973440 Date20 Oct 1997ClearedStatusActive

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  • Withdrawn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
KCT
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 REXAM Fracture Resistant Pouch is a medical device designed to enclose other medical devices for sterilization. It is intended for use by healthcare providers to ensure safe handling and storage of sterilized items.

The pouch is supplied in a sterile condition and is intended for single-use. It is compatible with steam and ethylene oxide sterilization methods. The device is regulated under FDA 510(k) clearance (K973440) and is manufactured by Rexam Medical Packaging, Inc.

Other devices from Rexam Medical Packaging, Inc.

Questions

AI-generated answers, 25 Sep 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 REXAM Fracture Resistant Pouch used for?

    It is a sterile, single-use medical pouch designed to enclose other medical devices for sterilization, ensuring their safe handling and storage.

  • What sterilization methods are compatible with this pouch?

    The REXAM Fracture Resistant Pouch is compatible with both steam and ethylene oxide sterilization methods.

  • Is the REXAM Fracture Resistant Pouch intended for single use?

    Yes, the device is intended for single-use and is supplied in a sterile condition.

  • How is the REXAM Fracture Resistant Pouch regulated?

    It is regulated under FDA 510(k) clearance (K973440) and is manufactured by Rexam Medical Packaging, Inc.