Athena Surgical RMUS System

GUDID 20860003619814

Mid-Urethral Sling Assembly, Round Needles

Athena Surgical LLC

Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer

• Primary Device ID: 20860003619814
• NIH Device Record Key: 73ffa0b1-0105-480c-9dd2-c0a965064d8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Athena Surgical RMUS System
• Version Model Number: 9001-1
• Company DUNS: 117067792
• Company Name: Athena Surgical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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 Dimensions

• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter
• Width: 1.1 Centimeter
• Length: 45 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003619810 [Primary]
GS1	10860003619817 [Package]; Contains: 00860003619810; Package: [15 Units]; In Commercial Distribution
GS1	20860003619814 [Package]; Contains: 00860003619810; 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: true

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

[20860003619814]

Ethylene Oxide

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