Vertessa Lite Strips 4x22cm

GUDID 00890594000384

Vertessa® Lite Strips, 4x22cm polypropylene mesh for sacrocolpopexy

CALDERA MEDICAL, INC.

Pelvic organ prolapse surgical mesh, composite-polymer
Primary Device ID00890594000384
NIH Device Record Key7022ff8a-8b75-466b-b720-7d37429ee4da
Commercial Distribution StatusIn Commercial Distribution
Brand NameVertessa Lite Strips 4x22cm
Version Model NumberCAL-VLY422ST
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
GS100890594000377 [Package]
Contains: 00890594000391
Package: box [3 Units]
In Commercial Distribution
GS100890594000384 [Package]
Contains: 00890594000391
Package: box [1 Units]
In Commercial Distribution
GS100890594000391 [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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