PMAM 10121 70mm 1600202-001

GUDID 07630055505033

Bien-Air Surgery SA

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Primary Device ID	07630055505033
NIH Device Record Key	1730bb5b-655a-4649-887c-fde7a80e4138
Commercial Distribution Discontinuation	2023-02-10
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	PMAM 10121 70mm
Version Model Number	1600202
Catalog Number	1600202-001
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	07630055505033 [Primary]
GS1	17630055505030 [Package] Package: [1 Units] Discontinued: 2023-02-10 Not in Commercial Distribution
HIBCC	J00716002020011 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K792159

FDA Product Code

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