Advantage Fit™ Blue System

GUDID 08714729961925

Transvaginal Mid-Urethral Sling

BOSTON SCIENTIFIC CORPORATION

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 08714729961925
• NIH Device Record Key: e18eca30-0d8a-4fdc-80f4-002d8b1f3f41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage Fit™ Blue System
• Version Model Number: M0068502120
• 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	08714729961925 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-01-22

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 00802526618208 - myLUX™ Patient App: 2025-04-21 For Insertable Cardiac Monitor
• 00802526618215 - myLUX™ Patient App: 2025-04-21 for Insertable Cardiac Monitor
• 00191506046330 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046347 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046354 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046361 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046378 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046385 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter