Home GUDID 05407005001134 Spirotome
Primary DI 05407005001134
Brand Spirotome
Company Bioncise
Model SS1408
Catalog number SS1408
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 stylet• A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula• A release elementThis presentation has an external diameter of 14G (2.5 mm) and length of 80 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 05407005000137 Package GS1 5 In Commercial Distribution 05407005001134 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05407005000137 05407005000137 5407005000137 05407005001134 05407005001134 5407005001134
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 06936666568636 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568643 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568650 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568667 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568674 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568681 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568698 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568704 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568711 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568728 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568735 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568742 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568759 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568766 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568773 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568780 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568797 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568803 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568810 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06936666568827 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06937278628268 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06937278628299 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06937278628305 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06937278628312 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06937278628329 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06937278628336 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06937278628343 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06937278628350 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06937278628367 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31 06937278628374 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-07-31