Navigation Software KNEE3 3.2 Installer 27001-01D

GUDID 04056481006860

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481006860
NIH Device Record Key2f7f2fad-7c0f-4541-ad48-60491019a654
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavigation Software KNEE3 3.2 Installer
Version Model Number3.2
Catalog Number27001-01D
Company DUNS314482980
Company NameBrainlab AG
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4989991568
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481006860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-10

On-Brand Devices [Navigation Software KNEE3 3.2 Installer]

040564811388063.2
040564810068603.2

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