USA Elite

GUDID 00821925036406

ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)

Gyrus Acmi, Inc.

Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00821925036406
• NIH Device Record Key: 9eabb57c-063b-437e-8a03-3c6a5294f854
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite
• Version Model Number: KE-24
• 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	00821925036406 [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: 5
• Public Version Date: 2023-07-26
• Device Publish Date: 2016-10-14

On-Brand Devices [USA Elite]

• 00821925038455: ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.015 Wire 2
• 00821925038448: ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.010 Wire 2
• 00821925038370: ACMI USA Elite System and USA Series Knife Electrode 28 FR (9.33mm)
• 00821925038363: ACMI USA Elite System and USA Series Knife Electrode 26 FR (8.667 mm)
• 00821925036413: ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 2
• 00821925036406: ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)