HS Stand. Burr, Ø4.0x70, 80k 1100569-001

GUDID 27630055507109

Bien-Air Surgery SA

Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use

• Primary Device ID: 27630055507109
• NIH Device Record Key: 563875e3-464e-4a68-9676-8314589fb51c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS Stand. Burr, Ø4.0x70, 80k
• Version Model Number: 360140 ES
• Catalog Number: 1100569-001
• Company DUNS: 481597719
• Company Name: Bien-Air Surgery SA
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	17630055507102 [Primary]
GS1	27630055507109 [Package]; Contains: 17630055507102; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• HBE: Drills, Burrs, Trephines & Accessories (Simple, Powered)

Sterilization

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

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

Devices Manufactured by Bien-Air Surgery SA

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• 27630055514732 - Bur PM2-70 80K diam C Ø3.1 St: 2024-04-09
• 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