DIEGO

GUDID 00821925026919

DIEGO FOOTSWITCH COUPLER JOINS DIEGO and DIEGO PK PEDALS

Gyrus ACMI, LLC

Electrosurgical handpiece, reusable

• Primary Device ID: 00821925026919
• NIH Device Record Key: 88b4c425-84fc-44b6-9ec3-c819007b31d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIEGO
• Version Model Number: 70339053
• Company DUNS: 007198742
• Company Name: Gyrus ACMI, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00821925026919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K034004

FDA Product Code

• ERL: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-04
• Device Publish Date: 2024-11-26

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