Osseoscalpel Microsaw G2

GUDID 07630055505590

Bien-Air Surgery SA

Sawing power tool attachment, reciprocating

• Primary Device ID: 07630055505590
• NIH Device Record Key: ca81fe08-6013-4ac3-8326-01741405cbe5
• Commercial Distribution Discontinuation: 2023-07-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Osseoscalpel Microsaw G2
• Version Model Number: 1600656
• Company DUNS: 481597719
• Company Name: Bien-Air Surgery SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	07630055505590 [Primary]
HIBCC	J00716006560011 [Secondary]

FDA Product Code

• DWI: Saw, Electrically Powered

Sterilization

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

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

[07630055505590]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-31
• Device Publish Date: 2023-07-21

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