Home GUDID 05407005001127 Spirotome
Primary DI 05407005001127
Brand Spirotome
Company Bioncise
Model SS1410
Catalog number SS1410
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 100 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 05407005000120 Package GS1 5 In Commercial Distribution 05407005001127 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05407005000120 05407005000120 5407005000120 05407005001127 05407005001127 5407005001127
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 00810131882983 BMAN BCOR Bone Marrow Aspirate Kit Surgentec, LLC KNW 2026-08-19 00810131884697 BMAN BCOR Bone Marrow Aspirate Kit (with Clip) Surgentec, LLC KNW 2026-08-19 00884450476079 CorVocet™ Merit Medical Systems, Inc. KNW 2026-08-18 00884450476093 CorVocet™ Merit Medical Systems, Inc. KNW 2026-08-18 06937278634917 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278634924 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278634931 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278634962 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278634979 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278634986 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635013 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635020 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635037 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635068 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635075 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635082 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635112 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635129 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635136 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635167 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635174 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635181 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635211 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635228 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635235 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635266 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635273 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635280 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635310 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635327 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15