PM2-Nose MIS P160 1502938-001

GUDID 17630055512601

Bien-Air Surgery SA

Drilling power tool attachment, basic
Primary Device ID17630055512601
NIH Device Record Key7eeea06d-d964-44ba-be2a-34fad7525cdb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePM2-Nose MIS P160
Version Model Number1502938
Catalog Number1502938-001
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 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
GS107630055512604 [Primary]
GS117630055512601 [Package]
Contains: 07630055512604
Package: [1 Units]
In Commercial Distribution

FDA Product Code

HBCMotor, Drill, Electric

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


[17630055512601]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-31
Device Publish Date2025-03-21

Devices Manufactured by Bien-Air Surgery SA

07630055508072 - PM2-S MIS2025-03-31
17630055508093 - PM2-Nose MIS D1502025-03-31
17630055512601 - PM2-Nose MIS P1602025-03-31
17630055512601 - PM2-Nose MIS P1602025-03-31
17630055506266 - Bur PM2-MIS D150 steel Ø2.0 St2025-03-31
17630055506273 - Bur PM2-MIS D150 steel Ø3.0 St2025-03-31
17630055506280 - Bur PM2-MIS D150 diam Ø2.0 St2025-03-31
17630055506297 - Bur PM2-MIS D150 diam Ø3.0 St2025-03-31
17630055506303 - Bur PM2-MIS D150 Mstick Ø1.8 St2025-03-31

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