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Mynxgrip MX5021

by Cordis US Corp.

Ref MX5021

Mynxgrip MX5021 is a Class III device made by Cordis US Corp., registered in EUDAMED on 14 Jun 2024 (Basic UDI-DI 07050320000000000000040CD) with CE/MDR certificate MDR 771921 valid until 22 Apr 2029, approved under FDA PMA P040044 on 17 Aug 2005 and listed in FDA GUDID since 23 Aug 2017 (UDI-DI 10862028000403), active as of 24 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

22 Apr 2029

CE MDR certificate

FDA recalls

2 ongoing

This device is named in the recall

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

PMA P040044

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 771921 Date11 Jun 2026IssuedStatusActive expires 22 Apr 2029
United StatesGUDID listing GUDID Number10862028000403 UDI-DI Date23 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP040044 Date17 Aug 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 07050320000000000000040CD registered 14 Jun 2024 Active· +1 more in the status table
  • FDA PMA P040044 decided 17 Aug 2005 Active
  • FDA GUDID UDI-DI 10862028000403 listed 23 Aug 2017 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 771921 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    11 Jun 2026
    Expires
    22 Apr 2029
    Reason
    Change approved

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

8 dated events

  1. Approved FDA PMA P040044
  2. Recall initiated FDA recalls Z-2329-2016
  3. Listed FDA GUDID 10862028000403
  4. Recall initiated FDA recalls Z-0675-2024
  5. Recall initiated FDA recalls Z-0674-2024
  6. Registered EUDAMED 07050320000000000000040CD
  7. Certificate issued EUDAMED MDR 771921
  8. Certificate expires EUDAMED MDR 771921

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
MYNXGRIP™ Vascular Closure Device 5F EUDAMED
Mynxgrip GUDID
Generic name
Wound hydrogel dressing, non-antimicrobial
Device name
MYNXGRIP™ Vascular Closure Device
Model / Ref / Catalog
MX5021
Primary DI / UDI-DI
10862028000403
Basic UDI-DI
07050320000000000000040CD
PMA number
FDA product code
MGB
EMDN code
H900304 Plugs
GMDN term
Wound hydrogel dressing, non-antimicrobial
Device class
Class III
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Wound hydrogel dressing, non-antimicrobial

Cleared under the same submission (P040044)

Similar devices in this category

Other devices filed under SUTURE REINFORCEMENT OR SUPPORT DEVICES.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)