BASCH-1 Micromotor + Cable 1700502-001

GUDID 17630055506150

Bien-Air Surgery SA

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• Primary Device ID: 17630055506150
• NIH Device Record Key: 465b3114-765a-4374-8f62-e02df4e69250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BASCH-1 Micromotor + Cable
• Version Model Number: 1700502
• Catalog Number: 1700502-001
• 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	17630055506150 [Primary]
HIBCC	J00717005020011 [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

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

Moist Heat or Steam Sterilization

[17630055506150]

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 [BASCH-1 Micromotor + Cable]

• J00717005020011: 1700502
• 17630055506150: 1700502