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 Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female 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 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 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 ID00890594000100
NIH Device Record Key50ea0fc6-cf7e-4611-8a4b-cd1486619597
Commercial Distribution StatusIn Commercial Distribution
Brand NameDesara TVez 2.7
Version Model NumberCAL-DS01TV27
Company DUNS130341956
Company NameCaldera Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100890594000100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-23
Device Publish Date2021-11-15

On-Brand Devices [Desara TVez 2.7]

00890594000100Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed inconti
00890594000131Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed inconti
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.