Spine & Trauma 3D Navigation

GUDID 04056481142025

Software for spine navigation

Brainlab AG

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Primary Device ID04056481142025
NIH Device Record Key1275fe46-7c9d-49a5-899d-f8b578d2ecb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpine & Trauma 3D Navigation
Version Model Number1,5
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481142025 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-21
Device Publish Date2020-02-13

On-Brand Devices [Spine & Trauma 3D Navigation ]

040564811403281.0
04056481142025Software for spine navigation

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