Home GUDID 00890594000971 Desara One
Primary DI 00890594000971
Brand Desara One
Company Caldera Medical, Inc.
Model CAL-DS2113
Device description Single Incision Sling System (3/box)
Published 2020-02-25
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 PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling General, Plastic Surgery 2 PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00890594000971 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 00890594000971 00890594000971 890594000971 0890594000971
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.
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 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 00857492008003 Transobturator Helical, Left Introducer Caldera Medical, Inc. PWJ 2022-08-03 00857492008010 Transobturator Helical, Right Introducer Caldera Medical, Inc. PWJ 2022-08-03 00890594000124 Desara Blue TVez 3.0 Caldera Medical, Inc. PWJ 2022-08-03 00890594000131 Desara TVez 2.7 Caldera Medical, Inc. PWJ 2022-08-03 00890594000155 Desara TVez 3.0 Caldera Medical, Inc. PWJ 2022-08-03 00890594000193 Desara Blue TVez 2.7 Caldera Medical, Inc. PWJ 2022-08-03 00890594000087 Desara Blue TVez 3.0 Caldera Medical, Inc. PWJ 2021-11-15 00890594000094 Desara Blue TVez 2.7 Caldera Medical, Inc. PWJ 2021-11-15 00890594000100 Desara TVez 2.7 Caldera Medical, Inc. PWJ 2021-11-15 00890594000117 Desara TVez 3.0 Caldera Medical, Inc. PWJ 2021-11-15 08437007606058 Needleless Sling DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL PAH 2020-10-19 00890594000957 Desara One Caldera Medical, Inc. PWJ 2020-02-25 00890594000957 Desara One Caldera Medical, Inc. PAH 2020-02-25 00890594000933 Transobturator Inside-Out, Right 3.2 mm Introducer Caldera Medical, Inc. PWJ 2019-11-05 00890594000940 Transobturator Inside-Out, Left 3.2 mm Introducer Caldera Medical, Inc. PWJ 2019-11-05 00890594000018 Transobturator Helical, Left Introducer Caldera Medical, Inc. PWJ 2019-09-30 00890594000148 Transobturator Helical, Right Introducer Caldera Medical, Inc. PWJ 2019-09-30 00890594000162 Transobturator Large Helical, Left Introducer Caldera Medical, Inc. PWJ 2019-09-30 00890594000179 Transobturator Large Helical, Right Introducer Caldera Medical, Inc. PWJ 2019-09-30 00890594000186 Transobturator Inside-Out, Left Introducer Caldera Medical, Inc. PWJ 2019-09-30 00890594000209 Transobturator Inside-Out, Right Introducer Caldera Medical, Inc. PWJ 2019-09-30 00890594000216 Transobturator Hook Introducer Caldera Medical, Inc. PWJ 2019-09-30 00890594000223 Suprapubic Introducer Caldera Medical, Inc. PWJ 2019-09-30 00890594000230 Transvaginal 4.0 mm Introducer Caldera Medical, Inc. PWJ 2019-09-30 00890594000278 Winged Guide Accessory Caldera Medical, Inc. PWJ 2019-09-30 00890594000865 Transvaginal 3.2 mm Introducer Caldera Medical, Inc. PWJ 2019-09-30 08714729961901 Solyx™ Blue BOSTON SCIENTIFIC CORPORATION PAH 2018-06-13 28032919892120 T-SLING HERNIAMESH SRL PAH 2016-08-05 00814723020036 MiniArc ENDO PHARMACEUTICALS INC. PAH 2015-10-24 00814723020104 MiniArc ENDO PHARMACEUTICALS INC. PAH 2015-10-24
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