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Quill PDO

by Surgical Specialties Mexico S. DE R.L. DE C.V. 119 variants

Ref RX-1069QModel Quill™ PDO (Polydioxanone)

Quill PDO (RX-1069Q) is a device classified as Class III in the EU and Class II in the US made by Surgical Specialties México, S. de R.L. de C.V., registered in EUDAMED on 2 Jul 2024 (Basic UDI-DI B-00848782019564) and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 00848782019564), active as of 22 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00848782019564 Basic UDI-DI 00848782019564UDI-DIDate2 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00848782019564 UDI-DI Date22 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00848782019564 registered 2 Jul 2024 Active
  • FDA GUDID UDI-DI 00848782019564 listed 22 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848782019564
  2. Registered EUDAMED B-00848782019564

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  • Withdrawn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
Quill PDO EUDAMED
2hr36 -0- Pdo 14x14 13mmleader GUDID
Generic name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Model / reference
Quill™ PDO (Polydioxanone), RX-1069Q
Primary DI / UDI-DI
00848782019564
Basic UDI-DI
B-00848782019564
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 registration type
Legacy device (under a directive)
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

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

Manufacturer details

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

Related devices

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

Similar devices in this category

Other devices filed under POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from Surgical Specialties México, S. de R.L. de C.V.

See all devices from Surgical Specialties México, S. de R.L. de C.V. →

Properties

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