Bur Cranial Spiral 10mm St 1101235-001

GUDID 17630055513837

Bien-Air Surgery SA

Cranial bur, single-use

• Primary Device ID: 17630055513837
• NIH Device Record Key: 2f741895-6f42-42a8-8d86-c28780d478f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bur Cranial Spiral 10mm St
• Version Model Number: 1101235
• Catalog Number: 1101235-001
• 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	17630055513837 [Primary]

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: 2024-12-12
• Device Publish Date: 2024-12-04

On-Brand Devices [Bur Cranial Spiral 10mm St]

• 27630055503514: 1100386
• 17630055513837: 1101235