USA Elite System

GUDID 00821925002104

USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 27.6 Fr, (9.2 mm) Color Coded White

Gyrus ACMI, LLC

Endoscope sheath, reusable

• Primary Device ID: 00821925002104
• NIH Device Record Key: c7bf72b9-f7ac-498a-b11b-f945a2239d86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite System
• Version Model Number: EOS-HCF27
• Company DUNS: 007198742
• Company Name: Gyrus ACMI, LLC
• 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: 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	00821925002104 [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

[00821925002104]

Moist Heat or Steam Sterilization

[00821925002104]

Moist Heat or Steam Sterilization

[00821925002104]

Moist Heat or Steam Sterilization

[00821925002104]

Moist Heat or Steam Sterilization

[00821925002104]

Moist Heat or Steam Sterilization

[00821925002104]

Moist Heat or Steam Sterilization

[00821925002104]

Moist Heat or Steam Sterilization

[00821925002104]

Moist Heat or Steam Sterilization

[00821925002104]

Moist Heat or Steam Sterilization

[00821925002104]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-29
• Device Publish Date: 2024-11-21

On-Brand Devices [USA Elite System]

• 00821925002104: USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 27.6 Fr, (9.2 mm) Color Co
• 00821925002487: Semi-Rigid Gynecologic Alligator Forceps 7 Fr (2.3 mm), 42 CM