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

Devices Manufactured by Gyrus ACMI, LLC

• 00821925040953 - GYRUS ACMI, INC: 2024-11-18 BULK PACK POLYETHYLENE DRAIN TUBES (50/PK)
• 00821925037892 - SAFETOUCH: 2024-11-15 SAFETOUCH Collection System, 3/8" (9.5 mm) (10/PK)
• 00821925038196 - BERKELEY: 2024-11-15 BERKELEY 1/2" (13 mm) PRIMARY COLLECTION BOTTLES (10/PK)
• 00821925037908 - Gyrus ACMI: 2024-10-29 Gauze Sack and O-Ring (10/PK)
• 00821925045361 - Olympus: 2024-10-17 Soltive 150 Micron single use ball tip fiber 2.0 (5/PK)
• 00821925045385 - Olympus: 2024-10-17 Soltive 150 Micron single use fiber 2.0 (5/PK)
• 00821925045408 - Olympus: 2024-10-17 Soltive 200 Micron single use ball tip fiber 2.0 (5/PK)
• 00821925045446 - Olympus: 2024-10-17 Soltive 365 Micron single use fiber 2.0 (5/PK)