ArcTV™ Transvaginal Sling System A-TV-1001

GUDID 00860368002401

ArcTV™ Transvaginal Sling System

UROCURE LLC

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 00860368002401
• NIH Device Record Key: 2b39e4de-02c1-41c9-a345-a494ae9571d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArcTV™ Transvaginal Sling System
• Version Model Number: A-TV-1001
• Catalog Number: A-TV-1001
• Company DUNS: 117159885
• Company Name: UROCURE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6124660117
• Email: info@urocure.com
• Phone: 6124660117
• Email: info@urocure.com
• Phone: 6124660117
• Email: info@urocure.com
• Phone: 6124660117
• Email: info@urocure.com
• Phone: 6124660117
• Email: info@urocure.com
• Phone: 6124660117
• Email: info@urocure.com
• Phone: 6124660117
• Email: info@urocure.com
• Phone: 6124660117
• Email: info@urocure.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860368002401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183134

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-21
• Device Publish Date: 2019-08-13