DIEGO

GUDID 00821925023277

DIEGO POWERED DISSECTOR DIAMOND BURR, IRRIGATING 3MM DIAMETER STRAIGHT

Gyrus ACMI, LLC

Metal/carbide ENT bur, single-use

• Primary Device ID: 00821925023277
• NIH Device Record Key: ae28ba23-f8a9-48b1-9835-f67681244753
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIEGO
• Version Model Number: 70138013
• Company DUNS: 007198742
• Company Name: Gyrus ACMI, LLC
• 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	00821925023277 [Package]; Contains: 00821925033801; Package: pack [6 Units]; In Commercial Distribution
GS1	00821925033801 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-02
• Device Publish Date: 2024-07-11

On-Brand Devices [DIEGO]

• 00821925023277: DIEGO POWERED DISSECTOR DIAMOND BURR, IRRIGATING 3MM DIAMETER STRAIGHT
• 00821925026933: REFURBISHED DIEGO PK FOOTSWITCH
• 00821925026919: DIEGO FOOTSWITCH COUPLER JOINS DIEGO and DIEGO PK PEDALS
• 00821925026902: DIEGO PK CABLE, RESPOSABLE WITH CABLE ORGANIZER 10’ (3 M) LENGTH SANTOPRENE