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Quill Monoderm

by Surgical Specialties Mexico S. DE R.L. DE C.V. 84 variants

Ref YA-1023Q-0Model Quill™ MONODERM™ Knotless Tissue-Closure Devices

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

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141558↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00848782021949 Basic UDI-DI 00848782021949UDI-DIDate5 Aug 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00848782021949 UDI-DI Date22 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK141558 Date11 Jul 2014IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Quill Monoderm EUDAMED
2de14 3-0 Undyd Monoderm 30x30 GUDID
Generic Name
Barbed polyester suture, non-antimicrobial
Model / Reference
Quill™ MONODERM™ Knotless Tissue-Closure Devices, YA-1023Q-0
Primary DI / UDI-DI
00848782021949
Basic UDI-DI
B-00848782021949
FDA Product Code
GAM
EMDN Code
H010101010301 Poliglecaprone and derivatives monofilament with needle
GMDN Term
Barbed polyester suture, non-antimicrobial
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
878.4493
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
MX-MF-000015841
Authorised representative
FSSB Chirurgische Nadeln GmbH DE-AR-000005767

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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