Home GUDID 00857492008096 Benesta Tissue Removal Device
Primary DI 00857492008096
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
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 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# 
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