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Hooks, Needles, Perforators

by SPIGGLE & THEIS Medizintechnik GmbH 5 variants

Ref 10-439-03

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250676741455 Basic UDI-DI 04250676741455UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250676741455 UDI-DI Date24 Sep 2025ListedStatusListed 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.

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  • Withdrawn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
Spatula
Generic Name
General-purpose surgical spatula
Device Name
Hooks, Needles, Perforators
Model / Ref / Catalog
10-439-03
Description
curved, long 15 cm
Primary DI / UDI-DI
04250676741455
Basic UDI-DI
B-04250676741455
FDA Product Code
GAF
EMDN Code
L14050103 Bone surgery spatulas, reusable
GMDN Term
General-purpose surgical spatula
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
DE-MF-000006647

Other devices from SPIGGLE & THEIS Medizintechnik GmbH

See all devices from SPIGGLE & THEIS Medizintechnik GmbH →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Serial Number: No
  • Expiration Date: No