GYNECARE TVT EXACT TVTRL

GUDID 10705031062375

Continence System

Ethicon Sàrl

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 10705031062375
• NIH Device Record Key: 58f65aec-0948-4567-b138-e836b5a3004b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GYNECARE TVT EXACT
• Version Model Number: TVTRL
• Catalog Number: TVTRL
• 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
• 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
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031062375 [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: 4
• Public Version Date: 2020-05-04
• Device Publish Date: 2015-09-23

Devices Manufactured by Ethicon Sàrl

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• 30705031468096 - SURGICEL NU-KNIT: 2023-05-23 Absorbable Hemostat (oxidized regenerated cellulose)
• 30705031468102 - SURGICEL: 2023-05-23 Absorbable Hemostat (oxidized regenerated cellulose)
• 30705031468119 - SURGICEL: 2023-05-23 Absorbable Hemostat (oxidized regenerated cellulose)
• 30705031468126 - SURGICEL: 2023-05-23 Absorbable Hemostat (oxidized regenerated cellulose)
• 30705031468133 - SURGICEL: 2023-05-23 Absorbable Hemostat (oxidized regenerated cellulose)
• 10705031002975 - SURGICEL NU-KNIT: 2023-04-24 Absorbable Hemostat (oxidized regenerated cellulose)
• 20705031003115 - SURGICEL FIBRILLAR: 2021-02-25 SURGICEL FIBRILLAR Absorbable Hemostats (oxidized regenerated cellulose)