Zethon

GUDID 15060528014769

BUR - 2.38MM, COARSE DIAMOND BALL, 150MM X 6.0MM

ZETHON LIMITED

Orthopaedic bur, single-use

• Primary Device ID: 15060528014769
• NIH Device Record Key: 3404d90f-0bbc-41f9-b7a0-2a45bed42b02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zethon
• Version Model Number: C15-06071
• Company DUNS: 774901748
• Company Name: ZETHON LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	05060528014762 [Primary]
GS1	15060528014769 [Package]; Contains: 05060528014762; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233958

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: 2025-05-15
• Device Publish Date: 2025-05-07

On-Brand Devices [Zethon]

• 15059358053840: BUR - 2.38MM, FLUTED BALL GOLD, 70MM X 1.5MM
• 15059358053826: BUR - 2.38MM, FLUTED BALL GOLD, 70MM X 1.0MM
• 15059358053802: BUR - 2.38MM, FLUTED BALL GOLD, 70MM X 0.5MM
• 15059358039929: BUR - 2.38MM, FLUTED BALL GOLD, 70MM X 2.5MM
• 15059358038618: BUR - 2.38MM, FLUTED BALL GOLD, 70MM X 3.0MM
• 15059358038571: BUR - 2.38MM, FLUTED BALL GOLD, 70MM X 2.0MM
• 15060528014684: BUR - 2.38MM, FINE DIAMOND BALL, 150MM X 5.0MM
• 15060528014646: BUR - 2.38MM, FINE DIAMOND BALL, 150MM X 4.0MM
• 15060528014608: BUR - 2.38MM, FINE DIAMOND MATCH, 150MM X 3.0MM
• 15060528014158: BUR - 2.38MM, FINE DIAMOND BALL, 70MM X 2.0MM
• 15060528014110: BUR - 2.38MM, FINE DIAMOND BALL, 70MM X 1.0MM
• 15059358055882: BUR - 2.38MM, FLUTED BALL S/CUT GOLD, 180MM X 3.0MM
• 15059358055868: BUR - 2.38MM, FLUTED BALL S/CUT GOLD, 120MM X 6.0MM
• 15059358055844: BUR - 2.38MM, FLUTED BALL S/CUT GOLD, 120MM X 5.0MM
• 15059358055820: BUR - 2.38MM, FLUTED BALL S/CUT GOLD, 120MM X 4.0MM
• 15059358055264: BUR - 2.38MM, FLUTED MATCH S/CUT GOLD, 180MM X 3.0MM
• 15059358055240: BUR - 2.38MM, FLUTED MATCH S/CUT GOLD, 180MM X 2.2MM
• 15059358055226: BUR - 2.38MM, FLUTED MATCH S/CUT GOLD, 120MM X 3.0MM
• 15059358055202: BUR - 2.38MM, FLUTED MATCH S/CUT GOLD, 120MM X 2.2MM
• 15059358055189: BUR - 2.38MM, FLUTED MATCH S/CUT GOLD, 100MM X 4.0MM
• 15059358054809: BUR - 2.38MM, DIAMOND BALL, 180MM X 3.0MM
• 15059358054793: BUR - 2.38MM, DIAMOND BALL, 150MM X 6.0MM
• 15059358054786: BUR - 2.38MM, DIAMOND BALL, 150MM X 5.0MM
• 15059358054779: BUR - 2.38MM, DIAMOND BALL, 150MM X 4.0MM
• 15059358054762: BUR - 2.38MM, DIAMOND BALL, 150MM X 3.0MM
• 15059358054755: BUR - 2.38MM, DIAMOND BALL, 150MM X 2.0MM
• 15059358054748: BUR - 2.38MM, DIAMOND BALL, 120MM X 6.0MM
• 15059358054731: BUR - 2.38MM, DIAMOND BALL, 120MM X 5.0MM
• 15059358054724: BUR - 2.38MM, DIAMOND BALL, 120MM X 4.0MM
• 15059358054717: BUR - 2.38MM, DIAMOND BALL, 120MM X 3.0MM
• 15059358054700: BUR - 2.38MM, DIAMOND BALL, 100MM X 6.0MM
• 15059358054694: BUR - 2.38MM, DIAMOND BALL, 100MM X 5.0MM
• 15059358054687: BUR - 2.38MM, DIAMOND BALL, 100MM X 4.0MM
• 15059358054670: BUR - 2.38MM, DIAMOND BALL, 100MM X 3.0MM
• 15059358054656: BUR - 2.38MM, DIAMOND BALL, 100MM X 2.0MM
• 15059358054632: BUR - 2.38MM, DIAMOND BALL, 100MM X 1.0MM
• 15059358054618: BUR - 2.38MM, DIAMOND BALL, 70MM X 8.0MM
• 15059358054595: BUR - 2.38MM, DIAMOND BALL, 70MM X 7.0MM
• 15059358054571: BUR - 2.38MM, DIAMOND BALL, 70MM X 6.0MM
• 15059358054557: BUR - 2.38MM, DIAMOND BALL, 70MM X 5.0MM
• 15059358054533: BUR - 2.38MM, DIAMOND BALL, 70MM X 4.0MM
• 15059358054519: BUR - 2.38MM, DIAMOND BALL, 70MM X 3.5MM
• 15059358054496: BUR - 2.38MM, DIAMOND BALL, 70MM X 3.0MM
• 15059358054472: BUR - 2.38MM, DIAMOND BALL, 70MM X 2.5MM
• 15059358054458: BUR - 2.38MM, DIAMOND BALL, 70MM X 2.0MM
• 15059358054434: BUR - 2.38MM, DIAMOND BALL, 70MM X 1.5MM
• 15059358054397: BUR - 2.38MM, FLUTED MATCH GOLD, 180MM X 3.0MM
• 15059358054373: BUR - 2.38MM, FLUTED MATCH GOLD, 180MM X 2.2MM
• 15059358054359: BUR - 2.38MM, FLUTED MATCH GOLD, 120MM X 3.0MM
• 15059358054335: BUR - 2.38MM, FLUTED MATCH GOLD, 120MM X 2.2MM