Desara TV

GUDID 00890594000803

Desara TV for the treatment of Stress Urinary Incontinence (SUI) or mixed incontinence.

CALDERA MEDICAL, INC.

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Primary Device ID00890594000803
NIH Device Record Key728b4e9e-3190-44bb-a882-c69253aa883d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDesara TV
Version Model NumberCAL-DS01TV
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
Phone1-818-879-6555
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

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Desara TV for SUI is recommended to be stored at room temperature in a clean dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100890594000803 [Package]
Contains: 00890594000827
Package: box [5 Units]
In Commercial Distribution
GS100890594000810 [Package]
Contains: 00890594000827
Package: box [1 Units]
In Commercial Distribution
GS100890594000827 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2017-01-16

On-Brand Devices [Desara TV ]

00890594000803Desara TV for the treatment of Stress Urinary Incontinence (SUI) or mixed incontinence.
00890594000919Desara TV for the treatment of Stress Urinary Incontinence (SUI) or mixed incontinence.
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