Drill Bit 4.5mm AO Shank Depth Control 60-100mm for Drill Guide

GUDID 04056481145866

Brainlab AG

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Primary Device ID	04056481145866
NIH Device Record Key	a5c1b7e7-677e-400a-980a-99d42b49680f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Drill Bit 4.5mm AO Shank Depth Control 60-100mm for Drill Guide
Version Model Number	41839-64
Company DUNS	314482980
Company Name	Brainlab AG
Device Count	1
DM Exempt	true
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	true
Serial Number	false
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	04056481145866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K221618

FDA Product Code

OLO	Orthopedic Stereotaxic Instrument