Set OSSEODOC + BASCH-1 1700541-001

GUDID 17630055506228

Bien-Air Surgery SA

Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered

Primary Device ID	17630055506228
NIH Device Record Key	e9435dd0-8a26-4c47-bfce-764ab25b9bd9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Set OSSEODOC + BASCH-1
Version Model Number	1700541
Catalog Number	1700541-001
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	true
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	17630055506228 [Primary]
HIBCC	J00717005410011 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K792159

FDA Product Code

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