TrueSight 5901-6102

GUDID 05420060362019

TSA guide and bone model

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit
Primary Device ID05420060362019
NIH Device Record Key06e22aad-6b8f-48c5-8b15-774350a7174b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrueSight
Version Model Number5901-6201
Catalog Number5901-6102
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
GS105420060362019 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05420060362019]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-27
Device Publish Date2019-07-19

On-Brand Devices [TrueSight]

05420060361012RSA guide and bone model
05420060362019TSA guide and bone model

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