Skip to content

Aesculap GC654R

by Aesculap, Inc.

Ref GC654R

Aesculap GC654R is a device classified as Class IIa in the EU and Class I in the US made by Aesculap, Inc., registered in EUDAMED on 10 Dec 2025 (Basic UDI-DI 40392390000026693F) and listed in FDA GUDID since 29 Jul 2022 (UDI-DI 04038653475131), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000026693F Basic UDI-DI 04038653475131UDI-DIDate10 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653475131 UDI-DI Date29 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000026693F registered 10 Dec 2025 Active
  • FDA GUDID UDI-DI 04038653475131 listed 29 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653475131
  2. Registered EUDAMED 40392390000026693F

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  • Withdrawn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
Aesculap
Generic name
Surgical saw blade, reciprocating, reusable
Device name
PS-Tools shank f reciprocating saw
Model / Ref / Catalog
GC654R
Primary DI / UDI-DI
04038653475131
Basic UDI-DI
40392390000026693F
FDA product code
HWE
EMDN code
Z12100980 Instruments for motorised neurosurgery systems - hardware accessories
GMDN term
Surgical saw blade, reciprocating, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

  • Supplied sterile
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)