PM 1124 46mm 1600612-001

GUDID 17630055505535

Bien-Air Surgery SA

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Primary Device ID	17630055505535
NIH Device Record Key	1fb22674-d9c4-494c-9fa1-2cf3d580d5b9
Commercial Distribution Status	In Commercial Distribution
Brand Name	PM 1124 46mm
Version Model Number	1600612
Catalog Number	1600612-001
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	07630055505538 [Primary]
GS1	17630055505535 [Package] Contains: 07630055505538 Package: [1 Units] In Commercial Distribution
HIBCC	J00716006120011 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K792159

FDA Product Code

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