Surgify Halo - 5.4 mm - Medium

GUDID 06429830116943

Surgify Medical Oy

Orthopaedic bur, single-use

• Primary Device ID: 06429830116943
• NIH Device Record Key: ad6405a8-f81b-4387-bdcd-8ecbd58f663a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgify Halo - 5.4 mm - Medium
• Version Model Number: 100-54-TM (US)
• Company DUNS: 368510617
• Company Name: Surgify Medical Oy
• Device Count: 1
• DM Exempt: false
• 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: false
• 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	06429830116943 [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: 2024-12-30
• Device Publish Date: 2024-12-20

Devices Manufactured by Surgify Medical Oy

• 06429811532069 - Surgify Halo | 4.0 mm | Short: 2025-06-26
• 06429811532076 - Surgify Halo | 4.0 mm | Extendable: 2025-06-26
• 06429811532083 - Surgify Halo | 4.0 mm | Long: 2025-06-26
• 06429811532090 - Surgify Halo | 5.4 mm | Short: 2025-04-10
• 06429811532106 - Surgify Halo | 5.4 mm | Long: 2025-04-10
• 06429811532120 - Surgify Halo | 5.4 mm | Medium: 2025-04-10
• 06429811532137 - Surgify Halo | 5.4 mm | Long: 2025-04-10
• 06429830116998 - Surgify Halo | 5.4 mm | Extendable: 2025-04-10