GYNECARE TVT 810041A

GUDID 10705031062283

Abdominal Guides

Ethicon Sàrl

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: 10705031062283
• NIH Device Record Key: 7f835a2f-9e69-4823-8aa7-7498bd15ddaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GYNECARE TVT
• Version Model Number: 810041A
• Catalog Number: 810041A
• Company DUNS: 480920383
• Company Name: Ethicon Sàrl
• 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: 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

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031062283 [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: 6
• Public Version Date: 2020-05-04
• Device Publish Date: 2015-09-23

On-Brand Devices [GYNECARE TVT]

• 10705031062306: Obturator system, Tension-free support for incontinence
• 10705031062290: Tension-free support, Blue Polypropylene Mesh Tape
• 10705031062283: Abdominal Guides
• 10705031062245: Reusable Rigid Catheter Guide
• 10705031062238: Reusable Introducer
• 10705031000346: Tension-free support for incontinence
• 10705031000322: Tension-free support, Blue Polypropylene Mesh Tape