Advantage Fit Ultra System M0068502160

GUDID 00191506007669

Transvaginal Mid-Urethral Sling

BOSTON SCIENTIFIC CORPORATION

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 00191506007669
• NIH Device Record Key: c6b98e3c-520f-48d9-bd37-fd1a64f2d669
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage Fit Ultra System
• Version Model Number: M0068502160
• Catalog Number: M0068502160
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00191506007669 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-14
• Device Publish Date: 2021-10-06

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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• 08714729037873 - Mardis Soft: 2025-05-19 Ureteral Stent Set
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• 08714729037927 - Mardis Soft: 2025-05-19 Ureteral Stent Set
• 08714729037934 - Mardis Soft: 2025-05-19 Ureteral Stent Set
• 08714729037996 - Mardis Soft: 2025-05-19 Ureteral Stent Set
• 08714729038009 - Mardis Soft: 2025-05-19 Ureteral Stent Set
• 08714729038016 - Mardis Soft: 2025-05-19 Ureteral Stent Set