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Precision 110010578

by Biomet Orthopedics, Inc.

Ref 110010578

Precision 110010578 is a device classified as Class IIa in the EU and Class I in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI B-00887868465826) and listed in FDA GUDID since 23 Jul 2021 (UDI-DI 00887868465826), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00887868465826 Basic UDI-DI 00887868465826UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868465826 UDI-DI Date23 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00887868465826 registered 19 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868465826 listed 23 Jul 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868465826
  2. Registered EUDAMED B-00887868465826

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  • Withdrawn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
Precision
Generic name
Medullary canal orthopaedic reamer, flexible
Device name
SM Precision Reamer
Model / Ref / Catalog
110010578
Primary DI / UDI-DI
00887868465826
Basic UDI-DI
B-00887868465826
FDA product code
HTO
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Medullary canal orthopaedic reamer, flexible
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
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.

Related devices

Category: Medullary canal orthopaedic reamer, flexible

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)