Home GUDID 00860014338663
SUREcore Plus Biopsy Instrument
Primary DI 00860014338663
Brand SUREcore Plus Biopsy Instrument
Company URO-1, INC.
Model SP-LA18-25
Catalog number SP-LA18-25
Device description "The SUREcore Plus Biopsy Instrument, with a length of 25 cm, facilitates biopsy of soft tissue. It consists of a biopsy needle and an instrument (""gun""). The needle is advanced under imaging to the target tissue and the instrument fires the needle into the tissue to obtain a core of tissue. The tissue core is than sent to pathology for analysis. It is a single-use device."
Published 2026-05-08
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 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 00860014338663 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 00860014338663 00860014338663 860014338663 0860014338663
GMDN Terms# Term, Definition table Term Definition Biopsy gun handpiece, mechanical A hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a reusable device.
Regulatory Flags# DUNS number 082407801 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 00860014338625 SUREcore Plus Biopsy Instrument SP-LA18-22 SP-LA18-22 2026-05-08
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841911103776 Mammotome Prima DEVICOR MEDICAL PRODUCTS, INC. KNW 2026-06-09 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