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Graft Fixation System 20034S

by Parcus Medical LLC

Ref 20034SModel Suture - Parcus Suture Tape

Graft Fixation System 20034S is a device classified as Class IIb in the EU and Class II in the US made by Parcus Medical LLC, registered in EUDAMED on 13 May 2026 (Basic UDI-DI B-00816342024280), cleared under FDA 510(k) K090923 on 30 Jun 2009 and listed in FDA GUDID since 16 Sep 2025 (UDI-DI 00816342024280), active as of 22 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K090923

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816342024280 Basic UDI-DI 00816342024280UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816342024280 UDI-DI Date16 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK090923 Date30 Jun 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00816342024280 registered 13 May 2026 Active
  • FDA 510(k) K090923 decided 30 Jun 2009 Active
  • FDA GUDID UDI-DI 00816342024280 listed 16 Sep 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K090923
  2. Listed FDA GUDID 00816342024280
  3. Registered EUDAMED B-00816342024280

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
1.6mm Sterile Tape Wh/Blk EUDAMED
Graft Fixation System GUDID
Generic name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / reference
20034S, Suture - Parcus Suture Tape
Primary DI / UDI-DI
00816342024280
Basic UDI-DI
B-00816342024280
510(k) Number
FDA product code
MBI
EMDN code
H0102010299 Synthetic nonabsorbable multifilament sutures - other
GMDN term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Polyester suture, non-bioabsorbable, multifilament

Cleared under the same submission (K090923)

and 8 more cleared under K090923

Similar devices in this category

Other devices filed under SYNTHETIC NONABSORBABLE MULTIFILAMENT SUTURES - OTHER.

Other devices from Parcus Medical LLC

See all devices from Parcus Medical LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)