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Pronova PN3307H

by Ethicon Inc.

Ref PN3307HModel PRONOVA Suture

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

CE MDR

Valid until

19 Jul 2028

CE MDR certificate

FDA recalls

None found

in data synced 7 Nov 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705031a020174G Basic UDI-DI 10705031238312UDI-DIDate23 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705031238312 UDI-DI Date5 May 2017ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 753195 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    25 Aug 2025
    Expires
    19 Jul 2028
    Reason
    Other

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 7 Nov 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Pronova
Generic Name
Polyolefin/fluoropolymer suture, monofilament
Device Name
PRONOVA Suture
Model / Ref / Catalog
PN3307H, PRONOVA Suture
Primary DI / UDI-DI
10705031238312
Basic UDI-DI
0705031a020174G
510(k) Number
FDA Product Code
GAW
EMDN Code
H010201010601 Polyvinylidene fluoride and derivatives monofilament with needle
GMDN Term
Polyolefin/fluoropolymer suture, monofilament
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
878.5010
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Polyolefin/fluoropolymer suture, monofilament

Cleared under the same submission (K001625)

Show all (12)

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

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