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Quill PPN

by Surgical Specialties Mexico S. DE R.L. DE C.V. 17 variants

Ref JA-1005QModel Quill Polypropylene Knotless Tissue-Closure Device Sterile Barbed Polypropylene Sutures

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00848782016891 Basic UDI-DI 00848782016891UDI-DIDate2 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00848782016891 UDI-DI Date21 Oct 2015ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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 PPN EUDAMED
2d13 -1- Cl Ppn 14 X 14 GUDID
Generic Name
Polyolefin/fluoropolymer suture, monofilament
Device Name
Quill PNN
Model / Ref / Catalog
Quill Polypropylene Knotless Tissue-Closure Device Sterile Barbed Polypropylene Sutures, JA-1005Q
Primary DI / UDI-DI
00848782016891
Basic UDI-DI
B-00848782016891
510(k) Number
FDA Product Code
GAW
EMDN Code
H010201010401 Polypropylene monofilament with needle for open surgery
GMDN Term
Polyolefin/fluoropolymer suture, monofilament
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.5010
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

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

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

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Properties

  • Sterile
  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • 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