Micro Ear Drill, 12k 1601126-001

GUDID 17630055506464

Bien-Air Surgery SA

Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered

• Primary Device ID: 17630055506464
• NIH Device Record Key: 5b7855b3-ab61-4c35-87c5-d8f286cc749f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro Ear Drill, 12k
• Version Model Number: 460000
• Catalog Number: 1601126-001
• 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: false
• 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	07630055506467 [Primary]
GS1	17630055506464 [Package]; Contains: 07630055506467; Package: [1 Units]; In Commercial Distribution

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: 2023-03-02
• Device Publish Date: 2023-02-22

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• 17630055515756 - Bur PM2-70 80K diam Ø0.6 St: 2024-04-09
• 17630055515763 - Bur PM2-70 80K diam Ø0.8 St: 2024-04-09
• 27630055515777 - Bur PM2-70 80K diam Ø1.0 St: 2024-04-09
• 27630055515784 - Bur PM2-70 80K diam Ø1.4 St: 2024-04-09
• 27630055515791 - Bur PM2-70 80K diam Ø1.8 St: 2024-04-09
• 27630055515807 - Bur PM2-70 80K diam Ø2.3 St: 2024-04-09