TruMatch Personalised Solutions Shoulder System 225501004

GUDID 05420060363108

TRUMATCH SHOULDER PSI APG GUIDE+GRAFT MODEL

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit
Primary Device ID05420060363108
NIH Device Record Key65805ec3-4f04-4ecf-8c18-aeed80521de9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruMatch Personalised Solutions Shoulder System
Version Model Number225501004
Catalog Number225501004
Company DUNS373139427
Company NameMaterialise NV
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105420060363108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

[05420060363108]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-27
Device Publish Date2018-05-14

On-Brand Devices [TruMatch Personalised Solutions Shoulder System]

05420060363122TRUMATCH SHOULDER PSI XTEND GUIDE+GRAFT MODEL
05420060363115TRUMATCH SHOULDER PSI STEPTECH GUIDE+GRAFT MODEL
05420060363108TRUMATCH SHOULDER PSI APG GUIDE+GRAFT MODEL
05420060363092TRUMATCH SHOULDER PSI XTEND GUIDE
05420060363085TRUMATCH SHOULDER PSI STEPTECH GUIDE
05420060363078TRUMATCH SHOULDER PSI APG GUIDE
05420060363061TRUMATCH SHOULDER PSI XTEND SCAPULA MODEL
05420060363054TRUMATCH SHOULDER PSI STEPTECH SCAPULA MODEL
05420060363047TRUMATCH SHOULDER PSI APG SCAPULA MODEL
05420060363191Guide and Bone model Shoulder Arthroplasty 3.5mm Center Pin
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