BASCH-1 Micromotor + Cable 1700502-001

GUDID J00717005020011

Bien-Air Surgery SA

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Primary Device ID	J00717005020011
NIH Device Record Key	a118b00d-66ce-45d1-a8bb-49f2149469f4
Commercial Distribution Discontinuation	2023-02-10
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	BASCH-1 Micromotor + Cable
Version Model Number	1700502
Catalog Number	1700502-001
Company DUNS	481597719
Company Name	Bien-Air Surgery SA
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	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
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
HIBCC	J00717005020011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K792159

FDA Product Code

ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece