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Sluder-Ballenger tonsillotome handle 40-351-10

by Spiggle & Theis Medizintechnik GmbH EUDAMEDGUDID

Active European Union

Ref 40-351-10

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number425038185G1501S9 Basic UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250381891285 UDI-DIDate6 Oct 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Sluder-Ballenger tonsillotome handle
Generic Name
Surgical instrument handle, non-torque-limiting
Device Name
Instrument Handles
Model / Ref / Catalog
40-351-10
Primary DI / UDI-DI
04250381891285
Basic UDI-DI
425038185G1501S9
Direct Marketing DI
04250381891285
FDA Product Code
GES
EMDN Code
L149099 ENT instruments, reusable - other
GMDN Term
Surgical instrument handle, non-torque-limiting
Device Class
Class I
Regulation Number
878.4800
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Spiggle & Theis Medizintechnik GmbH

See all devices from Spiggle & Theis Medizintechnik GmbH →

Properties

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

Other properties (20)

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