Bl Impactor Universal Thread M6 52855-40

GUDID 04056481002022

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481002022
NIH Device Record Key078abf14-908b-4a50-96ed-ed647a21ab9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBl Impactor Universal Thread M6
Version Model Number52855-40
Catalog Number52855-40
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481002022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481002022]

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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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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