PMRM 1122 95mm 1600340-001

GUDID J00716003400

Bien-Air Surgery SA

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Primary Device ID	J00716003400
NIH Device Record Key	f178bbb4-57c1-45dc-a1ae-bcd8f8ec0d75
Commercial Distribution Status	In Commercial Distribution
Brand Name	PMRM 1122 95mm
Version Model Number	1600340
Catalog Number	1600340-001
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	J00716003400 [Direct Marking]
HIBCC	J00716003400011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K792159

FDA Product Code

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