Desara Blue TV CAL-DS01BTV

GUDID 00890594000841

Desara Blue TV for the treatment of 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 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 ID00890594000841
NIH Device Record Key84eece7a-399b-4271-8a6f-15a0a11e14ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameDesara Blue TV
Version Model NumberCAL-DS01BTV
Catalog NumberCAL-DS01BTV
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100890594000834 [Package]
Contains: 00890594000858
Package: Box [5 Units]
In Commercial Distribution
GS100890594000841 [Package]
Contains: 00890594000858
Package: Box [1 Units]
In Commercial Distribution
GS100890594000858 [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 Date2019-10-08
Device Publish Date2019-09-30

Devices Manufactured by CALDERA MEDICAL, INC.

00857492008003 - Transobturator Helical, Left Introducer2022-08-11 Transobturator Helical, 3.2mm, Left Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion
00857492008010 - Transobturator Helical, Right Introducer2022-08-11 Transobturator Helical, 3.2mm, Right Introducer is a surgical mesh instrument to be used in surgical procedures for the insertio
00857492008041 - Benesta Hysteroscope Set2022-08-11 Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and
00857492008065 - Benesta Sterilization Tray 2022-08-11 The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Len
00857492008133 - Benesta Sterilization Tray2022-08-11 The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Len
00890594000070 - Desara Blue SL2022-08-11 Desara® Blue SL sling system for female stress urinary incontinence.
00890594000124 - Desara Blue TVez 3.02022-08-11 Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence
00890594000131 - Desara TVez 2.72022-08-11 Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.