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Hexagonal screw driver short 3.5mm AO small 78010169

by implantcast GmbH

Ref 78010169Model SH16SDSINST

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

CE MDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844SH16SDSINSTBS Basic UDI-DI 04048844546625UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844546625 UDI-DI Date31 Aug 2022ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Hexagonal screw driver short 3.5mm AO small
Generic Name
Surgical screwdriver, reusable
Model / Reference
78010169, SH16SDSINST
Primary DI / UDI-DI
04048844546625
Basic UDI-DI
4048844SH16SDSINSTBS
Direct Marketing DI
04048844546625
FDA Product Code
HXX
EMDN Code
L26 Surgical screwdrivers, reusable
GMDN Term
Surgical screwdriver, reusable
Device Class
Class I
Regulation Number
888.4540
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical screwdriver, reusable

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Reusable
  • CMR Substance
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No