USA Elite

GUDID 00821925028784

USA Elite System M3 Autoclavable Retrograde Telescope 110 Degrees, Color Coded Red

Gyrus Acmi, Inc.

Rigid endoscope telescope

• Primary Device ID: 00821925028784
• NIH Device Record Key: 3b69363a-038c-40c3-89da-06942411fcfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite
• Version Model Number: REXM3-110A
• 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: false
• Serial Number: true
• 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	00821925028784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890328

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

[00821925028784]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-22
• Device Publish Date: 2024-07-12

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