High-Speed Micro-Motor, large 1700763-001

GUDID 17630055506532

Bien-Air Surgery SA

Bone/joint surgical power tool motor, electric

• Primary Device ID: 17630055506532
• NIH Device Record Key: 6ac6f7d3-783c-4a16-843e-e41a58d2afc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: High-Speed Micro-Motor, large
• Version Model Number: 20362033
• Catalog Number: 1700763-001
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	17630055506532 [Primary]

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-27
• Device Publish Date: 2023-03-17

Devices Manufactured by Bien-Air Surgery SA

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• 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