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

• 17630055513752 - Bur PM2-150 80K Steel Ø4.0 St: 2024-12-12
• 17630055513769 - Bur PM2-150 80K Steel Ø3.1 St: 2024-12-12
• 17630055513783 - Bur PM2 80K Steel TD Ø1.1x5 St: 2024-12-12
• 17630055513790 - Bur PM2 80K Steel TD Ø1.1x4 St: 2024-12-12
• 17630055513813 - Bur Cranial Straight 25 mm St: 2024-12-12
• 17630055513820 - Bur Cranial Spiral 25mm St: 2024-12-12
• 17630055513837 - Bur Cranial Spiral 10mm St: 2024-12-12
• 17630055513844 - Bur Cranial Straight 10mm St: 2024-12-12