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Proximal Reaming Guide 8mm 155 deg

by Symmetry Medical Manufacturing, Inc.

Ref 14-135-000

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08475380451093D Basic UDI-DI 00847538018615UDI-DIDate6 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00847538018615 UDI-DI Date1 Sep 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Proximal Reaming Guide 8mm 155 deg EUDAMED
GLOBAL UNITE™ Short Stem Instrumentation GUDID
Generic Name
Orthopaedic reamer guide
Model / Reference
14-135-000 EUDAMED
210074800 GUDID
Primary DI / UDI-DI
00847538018615
Basic UDI-DI
08475380451093D
Direct Marketing DI
00847538018615
510(k) Number
FDA Product Code
PHX, KWS, HSD
EMDN Code
L0399 General surgery instruments, reusable - other
GMDN Term
Orthopaedic reamer guide
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3660, 888.3690
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
14-135-000
GUDID
210074800
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000025394
Authorised representative
SYMMETRY MEDICAL POLYVAC FR-AR-000003187

Other devices from Symmetry Medical Manufacturing, Inc.

See all devices from Symmetry Medical Manufacturing, Inc. →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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
  • Expiration Date: No