Athena Surgical RMUS System

GUDID 00860003619803

Instrument Handle

Athena Surgical LLC

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 00860003619803
• NIH Device Record Key: 55978725-7824-4d65-a9a6-06e7bee745e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Athena Surgical RMUS System
• Version Model Number: 9003
• Company DUNS: 117067792
• Company Name: Athena Surgical 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: 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	00860003619803 [Primary]
GS1	90860003619837 [Package]; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210087

FDA Product Code

• OTN: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Sterilization

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

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

[00860003619803]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [Athena Surgical RMUS System]

• 00860003619827: Mid-Urethral Sling Assembly, Flat Needles
• 20860003619814: Mid-Urethral Sling Assembly, Round Needles
• 00860003619803: Instrument Handle