Desara TVez 2.7

GUDID 00890594000100

Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Caldera Medical, Inc.

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 00890594000100
• NIH Device Record Key: 50ea0fc6-cf7e-4611-8a4b-cd1486619597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Desara TVez 2.7
• Version Model Number: CAL-DS01TV27
• Company DUNS: 130341956
• Company Name: Caldera Medical, Inc.
• 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: 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

Customer Support Contacts

• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-866-422-5337
• Email: info@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00890594000100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211975

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: 2021-11-23
• Device Publish Date: 2021-11-15

On-Brand Devices [Desara TVez 2.7]

• 00890594000100: Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed inconti
• 00890594000131: Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed inconti