PM2-A70HD 1600830-001

GUDID J00716008300

Bien-Air Surgery SA

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Primary Device ID	J00716008300
NIH Device Record Key	cb92b971-c702-447c-ac20-81c9eec7952b
Commercial Distribution Discontinuation	2023-02-09
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	PM2-A70HD
Version Model Number	1600830
Catalog Number	1600830-001
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	J00716008300 [Direct Marking]
HIBCC	J00716008300011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173066

FDA Product Code

HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)