Solyx™ Blue

GUDID 08714729961901

SIS System

BOSTON SCIENTIFIC CORPORATION

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

• 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

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