Home GUDID 00841912105977 Multi-Angle Biopsy Starter Kit
Primary DI 00841912105977
Brand Multi-Angle Biopsy Starter Kit
Company PROTEK MEDICAL PRODUCTS, INC.
Model 7285
Device description Multi Angle Biopsy Starter Kit for Samsung Medison LA4-18A & LA4-18AD Ultrasound Transducers
Published 2019-06-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841912105977 Direct Marking GS1 0 00841912106004 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 00841912105977 00841912105977 841912105977 0841912105977 00841912106004 00841912106004 841912106004 0841912106004
GMDN Terms# Term, Definition table Term Definition Body-surface ultrasound imaging transducer cover A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.
Sterilization Methods# Method table Method High-level Disinfectant
Regulatory Flags# DUNS number 965417181 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company#