ClearLens Knee Plane Tool 53238A

GUDID 04056481138738

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481138738
NIH Device Record Keyc47fea88-7a7b-47e4-8ab8-1436a5e2fac1
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearLens Knee Plane Tool
Version Model Number53238A
Catalog Number53238A
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 Batchfalse
Serial Numbertrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481138738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481138738]

Moist Heat or Steam Sterilization


[04056481138738]

Moist Heat or Steam Sterilization


[04056481138738]

Moist Heat or Steam Sterilization


[04056481138738]

Moist Heat or Steam Sterilization


[04056481138738]

Moist Heat or Steam Sterilization


[04056481138738]

Moist Heat or Steam Sterilization


[04056481138738]

Moist Heat or Steam Sterilization


[04056481138738]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-27
Device Publish Date2019-08-06

Devices Manufactured by Brainlab AG

04056481145439 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S2025-06-25
04056481145446 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L2025-06-25
04056481146320 - Alignment Software Spine2025-06-24 The Alignment Software Spine is intended to support the surgeon in reaching a predefined position through semi-automated alignme
04056481145521 - ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K)2025-06-23
04056481145538 - ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP) 2025-06-23
04056481145828 - Microscope Navigation 2025-06-19
04056481143985 - Mixed Reality Spine Navigation2025-06-09
04056481140809 - Curve 1.2 Dual Navigation Station2025-03-26

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