BASCH-1 Micromotor + Cable 1700502-001

GUDID 17630055506150

Bien-Air Surgery SA

Bone/joint surgical power tool motor, electric
Primary Device ID17630055506150
NIH Device Record Key465b3114-765a-4374-8f62-e02df4e69250
Commercial Distribution StatusIn Commercial Distribution
Brand NameBASCH-1 Micromotor + Cable
Version Model Number1700502
Catalog Number1700502-001
Company DUNS481597719
Company NameBien-Air Surgery SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117630055506150 [Primary]
HIBCCJ00717005020011 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


[17630055506150]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-20
Device Publish Date2023-02-10

On-Brand Devices [BASCH-1 Micromotor + Cable]

J007170050200111700502
176300555061501700502

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.