Home GUDID 00860014338625
SUREcore Plus Biopsy Instrument
Primary DI 00860014338625
Brand SUREcore Plus Biopsy Instrument
Company URO-1, INC.
Model SP-LA18-22
Catalog number SP-LA18-22
Device description "A needle biopsy system consisting of a needle and an instrument (""gun"") to facilitate biopsy of soft tissue. The needle is advanced to the target tissue under image guidance and then the instrument fires the needle in order to obtain a core of tissue that then is prepared for analysis by a pathologist."
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 00860014338618 Package GS1 1 In Commercial Distribution 00860014338625 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 00860014338618 00860014338618 860014338618 0860014338618 00860014338625 00860014338625 860014338625 0860014338625
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 00860014338663 SUREcore Plus Biopsy Instrument SP-LA18-25 SP-LA18-25 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