Home GUDID 27350081940076 NeoNavia Biopsy System
Primary DI 27350081940076
Brand NeoNavia Biopsy System
Company NeoDynamics AB (publ)
Model 2104
Catalog number 2104
Device description NeoNavia FlexiPulse probe
Published 2023-03-20
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FCG Biopsy Needle
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FCG Biopsy Needle Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 27350081940076 Package GS1 5 In Commercial Distribution 37350081940073 Package GS1 2 In Commercial Distribution 17350081940079 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 27350081940076 27350081940076 37350081940073 37350081940073 17350081940079 17350081940079
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.
Device Sizes# Type, Value, Unit table Type Value Unit Needle Gauge 14 Gauge
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 80 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Atmospheric Pressure 60 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 352793873 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes#