Set OSSEODOC + BASCH-1 1700541-001

GUDID 17630055506228

Bien-Air Surgery SA

Surgical power tool system control unit, line-powered

• Primary Device ID: 17630055506228
• NIH Device Record Key: e9435dd0-8a26-4c47-bfce-764ab25b9bd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Set OSSEODOC + BASCH-1
• Version Model Number: 1700541
• Catalog Number: 1700541-001
• 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: 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	17630055506228 [Primary]
HIBCC	J00717005410011 [Previous]

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

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

[17630055506228]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-20
• Device Publish Date: 2023-02-10

On-Brand Devices [Set OSSEODOC + BASCH-1]

• J00717005410011: 1700541
• 17630055506228: 1700541