Home GUDID 00890594000360 Vertessa Lite 10x26cm
Primary DI 00890594000360
Brand Vertessa Lite 10x26cm
Company Caldera Medical, Inc.
Model CAL-VL1026
Device description Vertessa Lite 10x26cm polypropylene mesh for sacrocolpopexy
Published 2016-05-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00890594000346 Package GS1 3 In Commercial Distribution 00890594000353 Package GS1 1 In Commercial Distribution 00890594000360 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00890594000346 00890594000346 890594000346 0890594000346 00890594000353 00890594000353 890594000353 0890594000353 00890594000360 00890594000360 890594000360 0890594000360
GMDN Terms# Term, Definition table Term Definition Pelvic organ prolapse surgical mesh, composite-polymer A woven/knitted or porous material comprised of both a bioabsorbable polymer (e.g., poliglecaprone 25) and a non-bioabsorbable polymer (e.g., polypropylene) intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor for the surgical treatment of vaginal pelvic organ prolapse (POP), including anterior, posterior, or apical prolapse repair. It is typically available with various material attributes (e.g., density, pore size, weave) and may be pre-configured for specific repair or cut to desired size/shape. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 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.
Regulatory Flags# DUNS number 130341956 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00857492008164 Benesta Hysteroscope Adapter CAL-TR1431 2022-07-19 00890594000124 Desara Blue TVez 3.0 CAL-DS01BTV30 2022-08-03 00890594000131 Desara TVez 2.7 CAL-DS01TV27 2022-08-03 00890594000155 Desara TVez 3.0 CAL-DS01TV30 2022-08-03 00890594000193 Desara Blue TVez 2.7 CAL-DS01BTV27 2022-08-03 00890594000087 Desara Blue TVez 3.0 CAL-DS01BTV30 2021-11-15 00890594000094 Desara Blue TVez 2.7 CAL-DS01BTV27 2021-11-15 00890594000100 Desara TVez 2.7 CAL-DS01TV27 2021-11-15 00890594000117 Desara TVez 3.0 CAL-DS01TV30 2021-11-15 00890594000230 Transvaginal 4.0 mm Introducer CAL-TV02 CAL-TV02 2019-09-30 00890594000865 Transvaginal 3.2 mm Introducer CAL-TV32 CAL-TV32 2019-09-30 00857492008041 Benesta Hysteroscope Set CAL-TR111 2022-08-03 00890594000933 Transobturator Inside-Out, Right 3.2 mm Introducer CAL-IOR32 CAL-IOR32 2019-11-05 00890594000940 Transobturator Inside-Out, Left 3.2 mm Introducer CAL-IOL32 CAL-IOL32 2019-11-05 00890594000018 Transobturator Helical, Left Introducer CAL-HL04 CAL-HL04 2019-09-30 00890594000148 Transobturator Helical, Right Introducer CAL-HR05 CAL-HR05 2019-09-30 00890594000162 Transobturator Large Helical, Left Introducer CAL-LHL1 CAL-LHL1 2019-09-30 00890594000179 Transobturator Large Helical, Right Introducer CAL-LHR2 CAL-LHR2 2019-09-30 00890594000186 Transobturator Inside-Out, Left Introducer CAL-IO6 CAL-IO6 2019-09-30 00890594000209 Transobturator Inside-Out, Right Introducer CAL-IO7 CAL-IO7 2019-09-30
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00890594000056 Desara Blue SL Caldera Medical, Inc. OTO 2022-08-03 00890594000070 Desara Blue SL Caldera Medical, Inc. OTO 2022-08-03 10705031202795 ARTISYN Johnson & Johnson Medical GmbH OTO 2019-01-29 00890594000339 Vertessa Lite 10x22cm Caldera Medical, Inc. OTO 2016-05-27 00890594000391 Vertessa Lite Strips 4x22cm Caldera Medical, Inc. OTO 2016-05-27 00890594000452 Vertessa Lite Y 22x5x4cm Caldera Medical, Inc. OTO 2016-05-27 00890594000704 Desara Blue OV Caldera Medical, Inc. OTO 2016-05-27 00890594000735 Desara Blue Short Suture Sling Caldera Medical, Inc. OTO 2016-05-27 00890594000643 Vertessa Lite 10x22cm CALDERA MEDICAL, INC. OTO 2016-05-27 00890594000384 Vertessa Lite Strips 4x22cm CALDERA MEDICAL, INC. OTO 2016-05-27 00890594000421 Vertessa Lite Y-mesh 22x4x3cm Caldera Medical, Inc. OTO 2016-05-27 00890594000445 Vertessa Lite Y 22x5x4cm CALDERA MEDICAL, INC. OTO 2016-05-27 00890594000766 Desara SL Caldera Medical, Inc. OTO 2016-05-27 00890594000698 Desara Blue OV CALDERA MEDICAL, INC. OTO 2016-05-27 00890594000728 Desara Blue Short Suture Sling CALDERA MEDICAL, INC. OTO 2016-05-27 00089059400766 Desara SL CALDERA MEDICAL, INC. OTO 2016-05-27 00890594000674 Desara Blue Caldera Medical, Inc. OTO 2016-05-26 00890594000797 Vertessa Lite Y-Mesh 26x5x4cm Caldera Medical, Inc. OTO 2015-10-30 00890594000483 Vertessa Lite Y-Mesh 26x4x3cm Caldera Medical, Inc. OTO 2015-10-30 00890594000773 Vertessa Lite Y-Mesh 26x5x4cm CALDERA MEDICAL, INC. OTO 2015-10-30 05708932483223 Restorelle Coloplast A/S OTO 2015-10-24 00814723020333 IntePro Y-Mesh ENDO PHARMACEUTICALS INC. OTO 2015-10-24 05708932483285 Restorelle Coloplast A/S OTO 2015-10-22 05708932483834 Restorelle Coloplast A/S OTO 2015-10-22 05708932483896 Restorelle Coloplast A/S OTO 2015-10-22 05708932483964 Restorelle Coloplast A/S OTO 2015-10-22 05708932528108 Restorelle Coloplast A/S OTO 2015-10-22 05708932553773 Coloplast Coloplast A/S OTO 2015-10-22 08714729839217 Upsylon™ BOSTON SCIENTIFIC CORPORATION OTO 2015-09-24 08714729839224 Polyform™ BOSTON SCIENTIFIC CORPORATION OTO 2015-09-24
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