HS Craniotome Burr,medium,80k 1100606-001

GUDID 27630055507475

Bien-Air Surgery SA

Cranial bur, single-use

• Primary Device ID: 27630055507475
• NIH Device Record Key: aeed6a98-8ef5-453f-b0c9-a0be26db8db5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS Craniotome Burr,medium,80k
• Version Model Number: 362640 M
• Catalog Number: 1100606-001
• 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	17630055507478 [Primary]
GS1	27630055507475 [Package]; Contains: 17630055507478; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173066

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

• 17630055513042 - Bur PM2-70 80K steel Ø3.5x80 sterile: 2026-02-19
• 17630055513059 - Bur PM2-70 80K steel Ø4.0x80 sterile: 2026-02-19
• 17630055513073 - Bur PM2-70 80K steel Ø5.0x80 sterile: 2026-02-19
• 17630055513394 - Bur PM2-95 80K steel Ø2 sterile: 2026-02-19
• 17630055513417 - Bur PM2-95 80K steel Ø3 sterile: 2026-02-19
• 17630055513486 - Bur PM2-125 80K steel Ø1 sterile: 2026-02-19
• 17630055513509 - Bur PM2-125 80K steel Ø2 sterile: 2026-02-19
• 17630055513523 - Bur PM2-125 80K steel Ø3 sterile: 2026-02-19