Home GUDID 00890594000674 Desara Blue
Primary DI 00890594000674
Brand Desara Blue
Company Caldera Medical, Inc.
Model CAL-DS01B
Device description Desara Blue sling system for female stress urinary incontinence.
Published 2016-05-26
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 00890594000650 Package GS1 5 In Commercial Distribution 00890594000667 Package GS1 1 In Commercial Distribution 00890594000674 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 00890594000650 00890594000650 890594000650 0890594000650 00890594000667 00890594000667 890594000667 0890594000667 00890594000674 00890594000674 890594000674 0890594000674
GMDN Terms# Term, Definition table Term Definition Stress urinary incontinence surgical mesh, female A sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may be referred to as a sling, tape, or subfascial hammock, and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., needles, sheaths) 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 Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures
Regulatory Flags# DUNS number 130341956 Device count 1 DM exempt true 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 00890594000360 Vertessa Lite 10x26cm 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 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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