Vertessa Lite Y-Mesh 26x4x3cm

GUDID 00890594000483

Vertessa Lite Y 26x4x3cm polypropylene mesh for sacrocolpopexy

CALDERA MEDICAL, INC.

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Primary Device ID00890594000483
NIH Device Record Key396c8a8e-5769-44c6-8934-dd595b81c6f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVertessa Lite Y-Mesh 26x4x3cm
Version Model NumberCAL-VLY2643
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
Phone1-818-879-6555
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 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Vertessa® Lite Y-Mesh Polypropylene Mesh for Sacrocolpopexy is recommended to be stored at room temperature in a clean dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100890594000469 [Package]
Package: BOX [3 Units]
In Commercial Distribution
GS100890594000476 [Package]
Package: Box [1 Units]
In Commercial Distribution
GS100890594000483 [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 Date2020-10-21
Device Publish Date2015-10-30

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