PM2-A125 1600769-001

GUDID J00716007690

Bien-Air Surgery SA

Drilling power tool attachment, basic
Primary Device IDJ00716007690
NIH Device Record Keyfa955069-6a05-49bf-a885-0464861fcccc
Commercial Distribution Discontinuation2023-02-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePM2-A125
Version Model Number1600769
Catalog Number1600769-001
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
HIBCCJ00716007690 [Direct Marking]
HIBCCJ00716007690011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

Moist Heat or Steam Sterilization


[J00716007690]

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-A125]

J007160076901600769
176300555057191600769

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