Home GUDID 07350181060045 Forsvall biopsy needle
Primary DI 07350181060045
Brand Forsvall biopsy needle
Company Xaga Surgical AB
Model Mech-00286
Catalog number 24171-14-04
Device description The Forsvall biopsy needle system for prostate biopsy consists of two items: the Forsvall biopsy needle and the Forsvall biopsy gun. TheForsvall biopsy needle is intended for use with the Forsvall biopsy gun. The Forsvall biopsy gun is reusable and the biopsy needle issingle use. The Forsvall biopsy system uses a spring loaded gun that mediates a biopsy needle with a side notch used to obtain tissuesamples. The biopsy gun is made of metal and hard plastic and the 16/18 gauge 10/15/20/25 cm biopsy needle is made of stainlessmedical grade steel.
Published 2025-06-02
Public version status Update
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 17350181060059 Package GS1 5 In Commercial Distribution 27350181060063 Package GS1 18 In Commercial Distribution 07350181060045 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17350181060059 17350181060059 27350181060063 27350181060063 07350181060045 07350181060045 7350181060045
GMDN Terms# Term, Definition table Term Definition End-cut biopsy gun needle An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. This is a single-use device.
Regulatory Flags# DUNS number 352977261 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07350181060076 Forsvall biopsy gun Mech-00669 24171-07-02 2025-06-09 07309861000079 Forsvall biopsy gun Mech-00669 24171-07-02 2025-06-09 07309861000048 Forsvall biopsy needle Mech-00286 24171-14-04 2025-06-02
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