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Blueprint™ Patient Specific Instrumentation MWJ004

by Tornier, Inc.

Ref MWJ004Model 3700386900168M

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3700386900168M Basic UDI-DI 93700386998976UDI-DIDate30 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number93700386998976 UDI-DI Date20 Mar 2018ListedStatusListed 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.

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  • Withdrawn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
Blueprint™ Patient Specific Instrumentation
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use
Device Name
Blueprint Instrumentation - Guiding Instrumentation - Class Iia - Non Sterile
Model / Ref / Catalog
MWJ004, 3700386900168M
Primary DI / UDI-DI
93700386998976
Basic UDI-DI
3700386900168M
FDA Product Code
KWS
EMDN Code
P091399 Orthopaedic implant instruments, single-use - other
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3660
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: 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