USA Elite

GUDID 00821925038370

ACMI USA Elite System and USA Series Knife Electrode 28 FR (9.33mm)

Gyrus Acmi, Inc.

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00821925038370
• NIH Device Record Key: 7a41a55a-d087-4a08-a550-62b3c22a6e92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite
• Version Model Number: KE-28
• 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	00821925002708 [Package]; Package: [6 Units]; In Commercial Distribution
GS1	00821925038370 [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)
• 00821925028784: USA Elite System M3 Autoclavable Retrograde Telescope 110 Degrees, Color Coded Red
• 00821925041813: USA Elite System and USA Series Roller Ball Electrode 28Fr (9.333 mm) Color Code Blue
• 00821925038851: ACMI USA Elite System and USA Series VaporTrode Vaporization Electrode Spiked Bar (6/PK)
• 00821925008113: ACMI USA Elite System and USA Series VaporTome Resection Electrode Grooved (6/PK)
• 00821925038653: ACMI USA Elite System and USA Series Self Sealing Seals (Black) (6/Pk)
• 00821925038646: ACMI USA ELITE SYSTEM AND USA SERIES BLIND SEALS (WHITE) (6/Pk)
• 00821925008175: USA Elite System Baumrucker Working Element