HS Dia.Burr,coarse,Ø2.3x70,80k 1100564-001

GUDID 27630055507055

Bien-Air Surgery SA

Diamond ENT bur, single-use

• Primary Device ID: 27630055507055
• NIH Device Record Key: 3e75f6ba-91d2-4cb9-8a9d-72c210122009
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS Dia.Burr,coarse,Ø2.3x70,80k
• Version Model Number: 360323 ES
• Catalog Number: 1100564-001
• 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	17630055507058 [Primary]
GS1	27630055507055 [Package]; Contains: 17630055507058; 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

• 17630055519426 - Bur PM2-70 80K steel Ø1.5x80 St: 2026-02-23
• 17630055519433 - Bur PM2-125 80K steel Ø1.5 St: 2026-02-23
• 17630055519440 - Bur PM2-70 80K diam EC Ø2.5x80 St: 2026-02-23
• 17630055519457 - Bur PM2-70 80K diam EC Ø3.0x80 St: 2026-02-23
• 17630055519464 - Bur PM2-70 80K diam EC Ø3.5x80 St: 2026-02-23
• 17630055519471 - Bur PM2-70 80K diamC Ø1.0x80 St: 2026-02-23
• 17630055519488 - Bur PM2-70 80K FC Ø2.5 St: 2026-02-23
• 17630055519495 - Bur PM2-70 80K diamC Ø1.5x80 St: 2026-02-23