PM2-S MIS 1601028-001

GUDID 07630055508072

Bien-Air Surgery SA

Drilling power tool attachment, basic
Primary Device ID07630055508072
NIH Device Record Key7214bd80-a955-4ec0-a687-9ae3f315723e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePM2-S MIS
Version Model Number1601028
Catalog Number1601028-001
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
GS107630055508072 [Primary]

FDA Product Code

HBCMotor, Drill, Electric

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

Moist Heat or Steam Sterilization


[07630055508072]

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

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17630055519440 - Bur PM2-70 80K diam EC Ø2.5x80 St2026-02-23
17630055519457 - Bur PM2-70 80K diam EC Ø3.0x80 St2026-02-23
17630055519464 - Bur PM2-70 80K diam EC Ø3.5x80 St2026-02-23
17630055519471 - Bur PM2-70 80K diamC Ø1.0x80 St2026-02-23
17630055519488 - Bur PM2-70 80K FC Ø2.5 St2026-02-23
17630055519495 - Bur PM2-70 80K diamC Ø1.5x80 St2026-02-23

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