Desara Blue TVez 3.0

GUDID 00890594000087

Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Caldera Medical, Inc.

Stress urinary incontinence surgical mesh, female
Primary Device ID00890594000087
NIH Device Record Key95332348-6fb2-4f8c-b830-22a99f9d22a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDesara Blue TVez 3.0
Version Model NumberCAL-DS01BTV30
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
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
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.
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
GS100890594000087 [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 Blue TVez 3.0]

00890594000087Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed in
00890594000124Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed in
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