PM 1124 46mm 1600612-001

GUDID J00716006120

Bien-Air Surgery SA

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Primary Device ID	J00716006120
NIH Device Record Key	d18e9a6d-596c-4e4f-8f47-14ef40c07518
Commercial Distribution Discontinuation	2023-02-09
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	PM 1124 46mm
Version Model Number	1600612
Catalog Number	1600612-001
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	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
HIBCC	J00716006120 [Direct Marking]
HIBCC	J00716006120011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K792159

FDA Product Code

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