HS Stand. Burr, Ø6.0x70, 80k 1100571-001

GUDID 27630055507123

Bien-Air Surgery SA

Metal/carbide ENT bur, single-use

• Primary Device ID: 27630055507123
• NIH Device Record Key: c97b991c-b686-42cd-b9e4-d348686d5f92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS Stand. Burr, Ø6.0x70, 80k
• Version Model Number: 360160 ES
• Catalog Number: 1100571-001
• 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	17630055507126 [Primary]
GS1	27630055507123 [Package]; Contains: 17630055507126; 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

• 17630055519419 - Bur PM2-70 80K steel Ø1.5 St: 2026-02-24
• 17630055519525 - Bur PM2-70 80K diam EC Ø4.0x80 St: 2026-02-24
• 27630055519539 - Bur PM2-70 80K steel Ø2.0 St: 2026-02-24
• 17630055519549 - Bur PM2-70 80K steel Ø2.0x80 St: 2026-02-24
• 17630055519556 - Bur PM2-70 80K diam Ø1.5 St: 2026-02-24
• 17630055519563 - Bur PM2-70 80K diam Ø1.5x80 St: 2026-02-24
• 17630055519570 - Bur PM2-70 80K diam EC Ø5.0x80 St: 2026-02-24
• 17630055519587 - Bur PM2-70 80K diamC Ø2.0 St: 2026-02-24