Athena Surgical RMUS System

GUDID 00860003619827

Mid-Urethral Sling Assembly, Flat Needles

Athena Surgical LLC

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 00860003619827
• NIH Device Record Key: 3edab67f-fd52-40cd-975a-bce074daa542
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Athena Surgical RMUS System
• Version Model Number: 9002-1
• 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: true
• 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	00860003619827 [Primary]
GS1	00860003619834 [Package]; Package: [15 Units]; In Commercial Distribution
GS1	10860003619824 [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: true

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

Ethylene Oxide

[00860003619827]

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