Home GUDID 00890594000018 Transobturator Helical, Left Introducer
Primary DI 00890594000018
Brand Transobturator Helical, Left Introducer
Company Caldera Medical, Inc.
Model CAL-HL04
Catalog number CAL-HL04
Device description Transobturator Helical, Left Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.
Published 2019-09-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00890594000018 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 00890594000018 00890594000018 890594000018 0890594000018
GMDN Terms# Term, Definition table Term Definition Transobturator needle, reusable A hand-held manual surgical instrument with a sharp pyramidal or conical point intended to be used to create a percutaneous puncture using the transobturator approach (i.e., insertion points overlie the obturator space and the obturator foramen membrane is penetrated), for the surgical positioning of a sling used in the treatment of stress urinary incontinence (SUI), which may be associated with a prolapse. The distal working end is typically made of a stainless steel rod that is markedly curved or helicoidal (right- or left-angled), with a pointed tip and an eye or notch to help position the sling. The device can be made of metal and/or polymer materials. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants.
Sterilization Methods# Method table Method Dry Heat Sterilization Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 130341956 Device count 1 DM exempt true Lot or batch true Sterilization required before use 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 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 00890594000216 Transobturator Hook Introducer CAL-TB03 CAL-TB03 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 00890594000957 Desara One Caldera Medical, Inc. PWJ 2020-02-25 00890594000971 Desara One Caldera Medical, Inc. PWJ 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 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
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