Home GUDID 05407005001257
Spirotome Spine
Primary DI 05407005001257
Brand Spirotome Spine
Company Bioncise
Model SS08SP
Catalog number SS08SP
Device description The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver.The Spirotome Biopsy Needle Set contains:• A two-part introducer needle that consists of a cutting cannula and a trocar• A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula- Injection needle• A release elementThis presentation has an external diameter of 8G (5 mm) and length of 150 mm.
Published 2018-08-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KNW Instrument, Biopsy
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KNW Instrument, Biopsy Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05407005000250 Package GS1 5 In Commercial Distribution 05407005001257 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05407005000250 05407005000250 5407005000250 05407005001257 05407005001257 5407005001257
GMDN Terms# Term, Definition table Term Definition Soft-tissue biopsy procedure kit, non-medicated A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.
Regulatory Flags# DUNS number 371402316 Device count 1 Kit true Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08800025901151 BEXCORE Breast Biopsy System MedicalPark CO.,LTD. KNW 2026-06-01 08800025902059 BEXCORE Breast Biopsy System MedicalPark CO.,LTD. KNW 2026-06-01 06937278635983 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278635990 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636003 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636010 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636027 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636034 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636041 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636058 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636065 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636072 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636089 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636096 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636102 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636119 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636126 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636133 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636140 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636157 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636164 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636171 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636188 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636195 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636201 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636218 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636225 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636232 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636249 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636256 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31