Set OSSEODOC 1700348-001

GUDID 17630055508147

Bien-Air Surgery SA

Surgical power tool system control unit, line-powered

• Primary Device ID: 17630055508147
• NIH Device Record Key: f2ceca64-0bd1-4d76-ab96-c648e75f5944
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Set OSSEODOC
• Version Model Number: 1700348
• Catalog Number: 1700348-001
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	17630055508147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K792159

FDA Product Code

• ERL: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Sterilization

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

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

[17630055508147]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-27
• Device Publish Date: 2023-02-17

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