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Coated VICRYL D8621

by Ethicon Inc.

Ref D8621Model VICRYL Suture

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

18 Jan 2028

CE MDR certificate

FDA recalls

1 ongoing

This device is named in the recall

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 719663 Date25 Aug 2026IssuedStatusActive expires 18 Jan 2028
United StatesGUDID listing GUDID Number10705031030718 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 719663 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    25 Aug 2026
    Expires
    18 Jan 2028
    Reason
    Other

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-2144-2024 FDA Class II initiated 10 May 2024

    Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

    • Terminated Z-0989-2020 FDA Class II initiated 3 Jan 2020

    Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.

    • Terminated Z-1087-06 FDA Unclassified (pre-2012) initiated 4 May 2006

    Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Coated VICRYL
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device Name
VICRYL Suture
Model / Ref / Catalog
D8621, VICRYL Suture
Primary DI / UDI-DI
10705031030718
Basic UDI-DI
0705031a0113148
510(k) Number
FDA Product Code
GAM
EMDN Code
H010101020201, H010101020202
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
878.4493
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Cleared under the same submission (K022269)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No