Mixed Reality Spine Navigation

GUDID 04056481146672

Brainlab AG

Electromagnetic/optical surgical navigation device tracking system
Primary Device ID04056481146672
NIH Device Record Key47c4f418-a31e-415f-ba2c-216d848c644f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMixed Reality Spine Navigation
Version Model Number1.1
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481146672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SBFOrthopedic Augmented Reality

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-08
Device Publish Date2025-07-31

On-Brand Devices [Mixed Reality Spine Navigation]

040564811439851.0
040564811466721.1

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