Vertessa Lite Y-mesh 22x4x3cm

GUDID 00890594000421

Vertessa Lite Y 22x4x3cm polypropylene mesh for sacrocolpopexy

CALDERA MEDICAL, INC.

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Primary Device ID00890594000421
NIH Device Record Key4d85a201-db0c-40d7-90fa-04d61d976c93
Commercial Distribution StatusIn Commercial Distribution
Brand NameVertessa Lite Y-mesh 22x4x3cm
Version Model NumberCAL-VL2243
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

Phone1-818-879-6555
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 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.

Device Identifiers

Device Issuing AgencyDevice ID
GS100890594000407 [Package]
Package: box [3 Units]
In Commercial Distribution
GS100890594000414 [Package]
Package: box [1 Units]
In Commercial Distribution
GS100890594000421 [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 Date2016-05-27

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