Set OSSEODOC + BASCH-1 1700541-001

GUDID J00717005410011

Bien-Air Surgery SA

Surgical power tool system control unit, line-powered

• Primary Device ID: J00717005410011
• NIH Device Record Key: 2bdcf225-4845-4886-92e3-af92dd329ed9
• Commercial Distribution Discontinuation: 2023-02-10
• Commercial Distribution Status: Not 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: true
• Serial Number: false
• 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
HIBCC	J00717005410011 [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

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

[J00717005410011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-13
• Device Publish Date: 2019-01-07

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

• J00717005410011: 1700541
• 17630055506228: 1700541