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Monodek IPN000864

by Teleflex Incorporated

Ref 833-137

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD EUDAMED NumberB-14026704603920 Basic UDI-DI 14026704603920UDI-DIDate22 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704603920 UDI-DI Date14 Jan 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Mdk VI Mf 0 TC43/HR26 48" EUDAMED
Monodek GUDID
Generic Name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Model / Ref / Catalog
833-137, IPN000864
Primary DI / UDI-DI
14026704603920
Basic UDI-DI
B-14026704603920
FDA Product Code
NEW
EMDN Code
H010101010101 Polydioxanone monofilament with needle for open surgery
GMDN Term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
878.4840
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
833-137
GUDID
IPN000864
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

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

Other devices from Teleflex Incorporated

See all devices from Teleflex Incorporated →

Properties

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

Other properties (19)

  • 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
  • Expiration Date: No
  • Manufacturing Date: No