PMAM 1221 125mm 1600339-001

GUDID J00716003390011

Bien-Air Surgery SA

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Primary Device ID	J00716003390011
NIH Device Record Key	3dfc10dc-211c-4ccd-923f-d193f39f94a2
Commercial Distribution Status	In Commercial Distribution
Brand Name	PMAM 1221 125mm
Version Model Number	1600339
Catalog Number	1600339-001
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	J00716003390 [Direct Marking]
HIBCC	J00716003390011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K792159

FDA Product Code

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