Vertessa Lite Y-Mesh 26x5x4cm

GUDID 00890594000773

Vertessa Lite Y 26x5x4cm polypropylene mesh for sacrocolpopexy

CALDERA MEDICAL, INC.

Pelvic organ prolapse surgical mesh, composite-polymer
Primary Device ID00890594000773
NIH Device Record Keya25075dc-60c6-4a20-95bb-15ed17844a52
Commercial Distribution StatusIn Commercial Distribution
Brand NameVertessa Lite Y-Mesh 26x5x4cm
Version Model NumberCAL-VLY2654
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
Phone1-818-879-6555
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
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be

Device Identifiers

Device Issuing AgencyDevice ID
GS100089059400797 [Primary]
GS100890594000773 [Package]
Contains: 00890594000797
Package: Box [3 Units]
In Commercial Distribution
GS100890594000780 [Package]
Contains: 00890594000797
Package: box [1 Units]
In Commercial Distribution
GS100890594000797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-26
Device Publish Date2015-10-30

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.