Desara TV CAL-DS01TV

GUDID 00890594000919

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

CALDERA MEDICAL, INC.

Stress urinary incontinence surgical mesh, female
Primary Device ID00890594000919
NIH Device Record Key46301887-5046-4906-8ba1-a5c1b860a78c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDesara TV
Version Model NumberCAL-DS01TV
Catalog 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

Device Dimensions

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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
GS100890594000902 [Primary]
GS100890594000919 [Package]
Contains: 00890594000902
Package: Box [1 Units]
In Commercial Distribution
GS100890594000926 [Package]
Contains: 00890594000902
Package: Box [5 Units]
In Commercial Distribution

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 Date2019-10-08
Device Publish Date2019-09-30

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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