Solyx™ SIS System

GUDID 08714729784784

SIS System

BOSTON SCIENTIFIC CORPORATION

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 08714729784784
• NIH Device Record Key: 9fe80a91-bf30-4dbe-b5b9-2cb63a63d34b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solyx™ SIS System
• Version Model Number: M0068507000
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	08714729774044 [Primary]
GS1	08714729784784 [Package]; Contains: 08714729774044; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• PAH: mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-23
• Device Publish Date: 2015-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729838005 - Capio SLIM: 2024-11-13 Suture Capturing Device
• 00191506043193 - FARAWAVE™ NAV: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043209 - FARAWAVE™ NAV: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043216 - FARAWAVE™: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043223 - FARAWAVE™: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043698 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator
• 00191506043704 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator
• 00191506043711 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator