BURR, 4MM ROUND CUTTING 10-25MM VAR EXPOSURE Diego Elite Drill 60MM

GUDID 00821925036512

BURR, 4MM ROUND CUTTING 10-25MM VAR EXPOSURE Diego Elite Drill 60MM, Length of burrSTD, Use with Sho

Gyrus Acmi, Inc.

Metal/carbide ENT bur, single-use

• Primary Device ID: 00821925036512
• NIH Device Record Key: 54ea30fc-573a-48f5-8279-790ff5a27018
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BURR, 4MM ROUND CUTTING 10-25MM VAR EXPOSURE Diego Elite Drill 60MM
• Version Model Number: MBUR4060FRCV
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00821925036512 [Primary]

FDA Product Code

• EQJ: BUR, EAR, NOSE AND THROAT

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: 2020-03-04
• Device Publish Date: 2020-02-25

Devices Manufactured by Gyrus Acmi, Inc.

• 00821925043916 - SOLTIVE: 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 150 Micron
• 00821925043930 - SOLTIVE: 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
• 00821925043978 - SOLTIVE: 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
• 00821925043992 - SOLTIVE: 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 365 Micron
• 00821925044074 - SOLTIVE: 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 940 Micron
• 00821925002074 - USA Elite System: 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
• 00821925002098 - USA Elite System: 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
• 00821925002111 - USA Elite System: 2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold