PMAM 1122 70mm 1600207-001

GUDID 07630055505057

Bien-Air Surgery SA

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Primary Device ID	07630055505057
NIH Device Record Key	1409e453-1ff4-4a39-84e6-84cb1848e314
Commercial Distribution Status	In Commercial Distribution
Brand Name	PMAM 1122 70mm
Version Model Number	1600207
Catalog Number	1600207-001
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	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	07630055505057 [Primary]
GS1	17630055505054 [Package] Package: [1 Units] In Commercial Distribution
HIBCC	J00716002070011 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K792159

FDA Product Code

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