VISIONAIRE UNI V0500001

GUDID 00885556700167

NONSTERILE VISIONAIRE UNI CUTTING GUIDE

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit
Primary Device ID00885556700167
NIH Device Record Keyca647895-ae09-42a9-854d-f9c82bf56c05
Commercial Distribution StatusIn Commercial Distribution
Brand NameVISIONAIRE UNI
Version Model NumberV0500001
Catalog NumberV0500001
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
GS100885556700167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


[00885556700167]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-27
Device Publish Date2018-04-10

On-Brand Devices [VISIONAIRE UNI]

00885556700204NONSTERILE VISIONAIRE UNI BONE MODEL
00885556700167NONSTERILE VISIONAIRE UNI CUTTING GUIDE

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