ClearLens Tracking Array Set for Knee 53236

GUDID 04056481005535

Brainlab AG

Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system
Primary Device ID04056481005535
NIH Device Record Keydafa82a8-7bc4-4fe7-b0f5-5a693fb71a11
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearLens Tracking Array Set for Knee
Version Model Number53236
Catalog Number53236
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 Usetrue
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+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481005535 [Primary]
GS104056481006709 [Package]
Package: [16 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

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

Devices Manufactured by Brainlab AG

04056481144753 - Drill Guide Array2024-06-12
04056481144760 - Drill Guide Depth Control (60 - 100 mm)2024-06-12
04056481144777 - Drill Guide Depth Control (0 - 60 mm)2024-06-12
04056481144784 - Drill Guide Tube (4.5 mm)2024-06-12
04056481144791 - Drill Guide Tube (3.2 mm)2024-06-12
04056481144807 - Drill Guide Tube (2.6 mm)2024-06-12
04056481144814 - Drill Guide Tube (2.4 mm)2024-06-12
04056481144821 - Drill Guide Tube (2.0 mm)2024-06-12

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