VarioGuide Joint Array Holder

GUDID 04056481144135

Brainlab AG

Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted

Primary Device ID	04056481144135
NIH Device Record Key	b5dca724-934e-49d3-8e68-8dd55e30ed4f
Commercial Distribution Status	In Commercial Distribution
Brand Name	VarioGuide Joint Array Holder
Version Model Number	55955-30
Company DUNS	314482980
Company Name	Brainlab AG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481144135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K223864

FDA Product Code

HAW	Neurological Stereotaxic Instrument