USA Elite System

GUDID 00821925002098

USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow

Gyrus Acmi, Inc.

General-purpose endoscopic needle, reusable

• Primary Device ID: 00821925002098
• NIH Device Record Key: ed388117-b5e8-4a23-b37c-692218393f5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite System
• Version Model Number: EOS-HCF25
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925002098 [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

[00821925002098]

Moist Heat or Steam Sterilization

[00821925002098]

Moist Heat or Steam Sterilization

[00821925002098]

Moist Heat or Steam Sterilization

[00821925002098]

Moist Heat or Steam Sterilization

[00821925002098]

Moist Heat or Steam Sterilization

[00821925002098]

Moist Heat or Steam Sterilization

[00821925002098]

Moist Heat or Steam Sterilization

[00821925002098]

Moist Heat or Steam Sterilization

[00821925002098]

Moist Heat or Steam Sterilization

[00821925002098]

Moist Heat or Steam Sterilization

[00821925002098]

Moist Heat or Steam Sterilization

[00821925002098]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-02
• Device Publish Date: 2024-07-25

On-Brand Devices [USA Elite System]

• 00821925001282: USA Elite System Accessory Working Element
• 00821925002173: USA Elite System Continuous Flow Resectoscope Outer Sheath 27.6 Fr, (9.2 mm) Color Coded Gray
• 00821925002166: USA Elite System Continuous Flow Resectoscope Outer Sheath 25.6 Fr, (8.5 mm) Color Coded Gold
• 00821925002159: USA Elite System Resectoscope Laser Bridge
• 00821925002128: USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 27.6 Fr, (9.2 mm) Color Code
• 00821925002111: USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Code
• 00821925002098: USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Co
• 00821925002074: USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color C