Cirq Robotic Biopsy Guide Tube Cranial

GUDID 04056481141585

Brainlab AG

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

Primary Device ID	04056481141585
NIH Device Record Key	6b8ca1c7-7303-427f-a99c-8df2b1290781
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cirq Robotic Biopsy Guide Tube Cranial
Version Model Number	56403
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	true
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	04056481141585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K210989

FDA Product Code

HAW	Neurological Stereotaxic Instrument