PMAM 1221 70 mm 1600295-001

GUDID 17630055505092

Bien-Air Surgery SA

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Primary Device ID	17630055505092
NIH Device Record Key	c670c7db-ed7b-4a14-bd4e-3c4f08a4dfe7
Commercial Distribution Status	In Commercial Distribution
Brand Name	PMAM 1221 70 mm
Version Model Number	1600295
Catalog Number	1600295-001
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	07630055505095 [Primary]
GS1	17630055505092 [Package] Contains: 07630055505095 Package: [1 Units] In Commercial Distribution
HIBCC	J00716002950011 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K792159

FDA Product Code

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