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Mynx Control MX5060

by Cordis US Corp.

Mynx Control MX5060 is a Class III device made by Cordis US Corp., approved under FDA PMA P040044 on 17 Aug 2005 and listed in FDA GUDID since 22 Oct 2018 (UDI-DI 10862028000427), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

PMA P040044

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10862028000427 UDI-DI Date22 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP040044 Date17 Aug 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P040044 decided 17 Aug 2005 Active
  • FDA GUDID UDI-DI 10862028000427 listed 22 Oct 2018 Listed

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0675-2024 FDA Class II initiated 28 Nov 2023
    • Ongoing Z-0674-2024 FDA Class II initiated 28 Nov 2023

    Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.

    • Terminated Z-2329-2016 FDA Class II initiated 13 Jul 2016

    A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.

Timeline

5 dated events

  1. Approved FDA PMA P040044
  2. Recall initiated FDA recalls Z-2329-2016
  3. Listed FDA GUDID 10862028000427
  4. Recall initiated FDA recalls Z-0675-2024
  5. Recall initiated FDA recalls Z-0674-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Mynx Control
Generic name
Wound hydrogel dressing, non-antimicrobial
Model / Ref / Catalog
MX5060
Primary DI / UDI-DI
10862028000427
PMA number
FDA product code
MGB
GMDN term
Wound hydrogel dressing, non-antimicrobial
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Wound hydrogel dressing, non-antimicrobial

Cleared under the same submission (P040044)

Similar devices in this category

Other devices filed under Wound hydrogel dressing, non-antimicrobial.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)