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ANSPACH Dissection Tools

by Synthes GmbH Switzerland EUDAMEDGUDID

Ref M-15SDC-G1

Product code HBEEMDN Z12130580

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08453840a0018D6 Basic UDI-DIDate30 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00845384016151 UDI-DIDate9 Sep 2016ListedStatusWithdrawn

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

39 recalls · FDA

    • Terminated Z-2837-2016 FDA Class II initiated 26 Aug 2016

    Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed.

  • 3 recalls, same reason

    • Terminated Z-2840-2016 FDA Class II initiated 26 Aug 2016
    • Terminated Z-2838-2016 FDA Class II initiated 26 Aug 2016
    • Terminated Z-2839-2016 FDA Class II initiated 26 Aug 2016

    The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.

  • 34 recalls, same reason

    • Terminated Z-2283-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2307-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2294-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2282-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2284-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2302-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2297-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2309-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2288-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2313-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2292-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2280-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2301-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2289-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2306-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2290-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2281-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2295-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2304-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2296-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2286-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2303-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2312-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2305-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2293-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2299-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2287-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2300-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2311-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2298-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2291-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2310-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2285-2015 FDA Class II initiated 13 Apr 2015
    • Terminated Z-2308-2015 FDA Class II initiated 13 Apr 2015

    G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.

    • Terminated Z-1377-2013 FDA Class II initiated 4 Mar 2011

    Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
ANSPACH Dissection Tools EUDAMED
Na GUDID
Generic Name
Cranial bur, single-use
Device Name
Cutting Tools - Dissection Tools
Model / Ref / Catalog
M-15SDC-G1
Primary DI / UDI-DI
00845384016151
Basic UDI-DI
08453840a0018D6
510(k) Number
FDA Product Code
HBE
EMDN Code
Z12130580 Motorised orthopaedic surgery system instruments - hardware accessories
GMDN Term
Cranial bur, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4310
Market of Registration
Belgium
Commercial Distribution
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000013345
Authorised representative
DePuy Ireland UC IE-AR-000009328

Other devices from Synthes GmbH

See all devices from Synthes GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • Implantable: No
  • Reusable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 4318ea1e-8f38-4d98-8baf-b5ace091d676 61 fields · synced 24 Oct 2026
  • FDA UDI 74302539-bf81-424b-afb6-061ee631296a 37 fields · synced 30 May 2026