USA Elite

GUDID 00821925008175

USA Elite System Baumrucker Working Element

Gyrus Acmi, Inc.

Resectoscope

• Primary Device ID: 00821925008175
• NIH Device Record Key: 5f5a83fa-ab27-49ff-b93b-4f9251497016
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite
• Version Model Number: REXEBWE
• 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: 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	00821925008175 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-01
• Device Publish Date: 2024-07-24

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