Home GUDID G6357714101 BIOCORE II TC
Primary DI G6357714101
Brand BIOCORE II TC
Company HISTO S.A.
Model 14 Ga x 10 cm
Catalog number 771410
Device description Biopsy Needles Biocore II TC
Published 2024-05-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DWO Needle, Biopsy, Cardiovascular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DWO Needle, Biopsy, Cardiovascular General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G6357714101 Package HIBCC 5 In Commercial Distribution G635771410 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Side-notch 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 small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is a percutaneously-inserted needle with a side-notch cutter at the distal end which when activated causes a sharp, sliding cannula to slice a segment of tissue. 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 single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 15 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 971156914 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false 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 false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published G635360015 DANA 2.2 MG G 22 mm 360015 2024-05-17 G635360015G1 DANA 2.2 MG G 0- 22 mm 360015G 2024-05-17 G635212005 MAMAWIRE 20 Ga x 5 cm 212005 2024-05-17 G635212007 MAMAWIRE 20 Ga x 7 cm 212007 2024-05-17 G635212010 MAMAWIRE 20 Ga x 10 cm 212010 2024-05-17 G635212012 MAMAWIRE 20 Ga x 12 cm 212012 2024-05-17 G635212013 MAMAWIRE 20 Ga x 13 cm 212013 2024-05-17 G635212015 MAMAWIRE 20 Ga x 15 cm 212015 2024-05-17 G635312005 MAMAWIRE PLUS 20 Ga x 5 cm 312005 2024-05-17 G635312007 MAMAWIRE PLUS 20 Ga x 7 cm 312007 2024-05-17 G635312010 MAMAWIRE PLUS 20 Ga x 10 cm 312010 2024-05-17 G635312012 MAMAWIRE PLUS 20 Ga x 12 cm 312012 2024-05-17 G635312013 MAMAWIRE PLUS 20 Ga x 13 cm 312013 2024-05-17 G635312015 MAMAWIRE PLUS 20 Ga x 15 cm 312015 2024-05-17 G635812020 BLO-K 20 Ga x 20 cm 812020 2024-05-17 G635812025 BLO-K 20 Ga x 25 cm 812025 2024-05-17 G635911810 MAMAWIRE FIX 18 Ga x 10 cm 911810 2024-05-17 G635911810B1 MAMAWIRE FIX 18 Ga x 10 cm 911810B 2024-05-17 G635911810D1 MAMAWIRE FIX 18 Ga x 10 cm 911810D 2024-05-17 G635911810DB1 MAMAWIRE FIX 18 Ga x 10 cm 911810DB 2024-05-17
Other Devices Sharing Product Codes# 
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