Spine Planning

GUDID 04056481141998

software

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481141998
NIH Device Record Keya616865d-a3ff-4364-8288-f4b4e0715498
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpine Planning
Version Model Number1,0
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
GS104056481141998 [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 Planning]

04056481141998software
040564811439162.0

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