PM2-A MIS 1601027-001

GUDID 07630055508065

Bien-Air Surgery SA

Drilling power tool attachment, basic

• Primary Device ID: 07630055508065
• NIH Device Record Key: 34c7d6f4-d496-4e84-98fb-b92045424c9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PM2-A MIS
• Version Model Number: 1601027
• Catalog Number: 1601027-001
• Company DUNS: 481597719
• Company Name: Bien-Air Surgery SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630055508065 [Primary]

FDA Product Code

• HBC: Motor, Drill, Electric

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

[07630055508065]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

Devices Manufactured by Bien-Air Surgery SA

• 07630055508072 - PM2-S MIS: 2025-03-31
• 17630055508093 - PM2-Nose MIS D150: 2025-03-31
• 17630055512601 - PM2-Nose MIS P160: 2025-03-31
• 17630055506266 - Bur PM2-MIS D150 steel Ø2.0 St: 2025-03-31
• 17630055506273 - Bur PM2-MIS D150 steel Ø3.0 St: 2025-03-31
• 17630055506280 - Bur PM2-MIS D150 diam Ø2.0 St: 2025-03-31
• 17630055506297 - Bur PM2-MIS D150 diam Ø3.0 St: 2025-03-31
• 17630055506303 - Bur PM2-MIS D150 Mstick Ø1.8 St: 2025-03-31