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Acumed 80-1592

by Acumed LLC

Part of a family of 19 devices: see the family page

Ref 80-1592Model ACUTRAK 3 PROFILE DRILL

Acumed 80-1592 is a device classified as Class IIa in the EU and Class I in the US made by Acumed LLC, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 0806378BUDI33PZ) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378050152), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0806378BUDI33PZ Basic UDI-DI 10806378050152UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378050152 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0806378BUDI33PZ registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378050152 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378050152
  2. Registered EUDAMED 0806378BUDI33PZ

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  • Withdrawn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
Polarus 3 EUDAMED
Acumed GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Model / reference
80-1592, ACUTRAK 3 PROFILE DRILL
Description
Polarus® 3 2.8mm Short Drill
Primary DI / UDI-DI
10806378050152
Basic UDI-DI
0806378BUDI33PZ
FDA product code
LXH
EMDN code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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.

Related devices

Category: General internal orthopaedic fixation system implantation kit

Similar devices in this category

Other devices filed under INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)