Pinless Femur Reference Array 52400-01A

GUDID 04056481002411

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481002411
NIH Device Record Keyec7a7b6e-de33-474c-9130-b8dec0a109dc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePinless Femur Reference Array
Version Model Number52400-01A
Catalog Number52400-01A
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481002411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481002411]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

Devices Manufactured by Brainlab AG

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04056481146238 - PATIENT REFERENCE ARRAY SPINE & TRAUMA2024-11-22
04056481146603 - ADAPTER SHORT FOR PATIENT REFERENCE CLAMP2024-11-22
04056481146610 - ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY2024-11-22
04056481143916 - Spine Planning2024-11-13
04056481144654 - Viewer 5.42024-11-13
04056481143527 - DICOM Proxy2024-11-01

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