Home GUDID 00857492008102 Benesta Tissue Removal Device
Primary DI 00857492008102
Brand Benesta Tissue Removal Device
Company Caldera Medical, Inc.
Model CAL-TR1511
Device description The Benesta Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.
Published 2022-07-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name HIH Hysteroscope (And Accessories)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HIH Hysteroscope (And Accessories) Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00857492008102 Package GS1 3 In Commercial Distribution 00857492008096 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 00857492008102 00857492008102 857492008102 0857492008102 00857492008096 00857492008096 857492008096 0857492008096
GMDN Terms# Term, Definition table Term Definition Tissue morcellation system handpiece, battery-powered A battery-powered, hand-held device intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery (e.g., prostate tissue morcellation during laparoscopy). It consists of a cordless instrument with a high-speed rotating blade in a holder. Resected tissue may be removed through suction or manually with a grasping instrument. This is a single-use device.
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 location
Regulatory Flags# DUNS number 130341956 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 06974880994053 Manual Tissue Removal Device Suzhou AcuVu medical technology Co., Ltd. HIH 2026-07-27 06974880994084 Manual Tissue Removal Device Suzhou AcuVu medical technology Co., Ltd. HIH 2026-07-27 06975339623418 SeleneView® MacroLux Medical Technology Co., Ltd. HIH 2026-07-03 00821925002104 USA Elite System Gyrus ACMI, LLC HIH 2024-11-21 00821925002074 USA Elite System Gyrus ACMI, LLC HIH 2024-07-25 00821925002562 SlimLine Gyrus ACMI, LLC HIH 2024-07-24 07613327616675 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616682 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616699 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616705 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616712 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616729 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616736 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616743 SPY STRYKER CORPORATION HIH 2024-02-27 07613327624311 NA STRYKER CORPORATION HIH 2024-02-27 07613327507102 N/A STRYKER SUSTAINABILITY SOLUTIONS, INC. HIH 2020-10-26 07613327507119 N/A STRYKER SUSTAINABILITY SOLUTIONS, INC. HIH 2020-10-26 07613327507126 N/A STRYKER SUSTAINABILITY SOLUTIONS, INC. HIH 2020-10-26 07613327507133 N/A STRYKER SUSTAINABILITY SOLUTIONS, INC. HIH 2020-10-26 07613327507140 N/A STRYKER SUSTAINABILITY SOLUTIONS, INC. HIH 2020-10-26 08714729986935 Cytuity™ BOSTON SCIENTIFIC CORPORATION HIH 2019-08-20 10884521750203 TruClear Covidien LP HIH 2018-12-21 00821925004986 Gyrus ACMI Gyrus ACMI, LLC HIH 2018-09-13 10884521744080 TruClear Covidien LP HIH 2017-10-16 10884521744097 TruClear Covidien LP HIH 2017-10-16 10884521744103 TruClear Covidien LP HIH 2017-10-16 10884521744110 TruClear Covidien LP HIH 2017-10-16 M648C0100110 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN OBP CORPORATION HIH 2016-11-11 M648C0100120 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO OBP CORPORATION HIH 2016-11-11 00821925001862 USA Series Gyrus ACMI, LLC HIH 2016-10-14
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