ACMI USA Elite System and USA Series Straight Cutting Loop Electrode

GUDID 00821925007543

Gyrus Acmi, Inc.

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00821925007543
• NIH Device Record Key: f8901489-f56f-4461-94ef-1be06e0ffbbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACMI USA Elite System and USA Series Straight Cutting Loop Electrode
• Version Model Number: MLES-26-015
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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: 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	00821925007543 [Package]; Contains: 00821925038516; Package: [12 Units]; In Commercial Distribution
GS1	00821925038516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890328

FDA Product Code

• FAS: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-14

On-Brand Devices [ACMI USA Elite System and USA Series Straight Cutting Loop Electrode]

• 00821925007543: MLES-26-015
• 00821925007536: MLES-24-015