PM2-A70HD 1600830-001

GUDID J00716008300

Bien-Air Surgery SA

Drilling power tool attachment, basic
Primary Device IDJ00716008300
NIH Device Record Keycb92b971-c702-447c-ac20-81c9eec7952b
Commercial Distribution Discontinuation2023-02-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePM2-A70HD
Version Model Number1600830
Catalog Number1600830-001
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
HIBCCJ00716008300 [Direct Marking]
HIBCCJ00716008300011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


[J00716008300]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-02-10
Device Publish Date2019-01-07

On-Brand Devices [PM2-A70HD]

J007160083001600830
176300555057571600830

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