Solyx™ Blue

GUDID 08714729961901

SIS System

BOSTON SCIENTIFIC CORPORATION

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 08714729961901
• NIH Device Record Key: 9d310a8f-d90a-4f13-9c71-08285af4f10b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solyx™ Blue
• Version Model Number: M0068507010
• 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	08714729961901 [Primary]

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: 2
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-06-13

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729298151 - NA: 2024-10-17 Connecting Tube with stopcock
• 00191506055301 - OPAL HDx™: 2024-10-16 Mapping System Workstation PC
• 00191506055325 - OPAL HDx™: 2024-10-16 Mapping System Signal Station
• 00191506055370 - OPAL HDx™: 2024-10-16 Mapping System
• 08714729848097 - Colpassist: 2024-10-16 Vaginal Positioning Device
• 08714729784432 - Percutaneous Tract Kit: 2024-10-11 Percutaneous Tract Kit
• 08714729789536 - Lingeman Percutaneous Tract Kit: 2024-10-11 Percutaneous Tract Kit
• 08714729010944 - NA: 2024-10-10 Connecting Tube for 3F through 6F Catheters