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Carilaginator 170-01250-S

by Extremity Medical, LLC

Ref 170-01250-S

Carilaginator 170-01250-S is a device classified as Class IIa in the EU and Class I in the US made by Extremity Medical, LLC, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-00842078134085) and listed in FDA GUDID since 9 Jun 2026 (UDI-DI 00842078134085), active as of 7 Nov 2026.

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

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00842078134085 Basic UDI-DI 00842078134085UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842078134085 UDI-DI Date9 Jun 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00842078134085 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 00842078134085 listed 9 Jun 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00842078134085
  2. Registered EUDAMED B-00842078134085

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Advanced Joint Prep Instrumentation - Sterile EUDAMED
Carilaginator GUDID
Generic name
Bone file/rasp, reciprocating, single-use
Model / reference
170-01250-S
Primary DI / UDI-DI
00842078134085
Basic UDI-DI
B-00842078134085
FDA product code
HWE
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Bone file/rasp, reciprocating, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Supplied sterileEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 00842078134085: EUDAMED states No, FDA GUDID states Yes.

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 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Extremity Medical, LLC

See all devices from Extremity Medical, LLC →

Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)