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Surgicel Fibrillar 431961

by Ethicon Inc.

Ref 431961

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-USMF000013112000200K3 Basic UDI-DI D-USMF000013112000200K3UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-USMF000013112000200K3 UDI-DI Date20 Sep 2014ListedStatusListed GUDID: not 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 24 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  • Withdrawn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
Tabotamp Fibrillar EUDAMED
Surgicel Fibrillar GUDID
Generic Name
Plant polysaccharide haemostatic agent, bioabsorbable
Model / Ref / Catalog
431961
Primary DI / UDI-DI
D-USMF000013112000200K3 EUDAMED
10705031005358 GUDID
Basic UDI-DI
B-USMF000013112000200K3
FDA Product Code
LMG
EMDN Code
M040501 Polysaccharide haemostatic dressings
GMDN Term
Plant polysaccharide haemostatic agent, bioabsorbable
Device Class
Class III
Regulation Number
878.4490
EU market of registration
Belgium
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-USMF000013112000200K3
GUDID
10705031005358

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Cleared under the same submission (N12159)

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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