Home GUDID G635551213 BIOCORE II MG
Primary DI G635551213
Brand BIOCORE II MG
Company HISTO S.A.
Model 12 Ga x 13 cm
Catalog number 551213
Device description Biopsy Needle Biocore II MG
Published 2024-05-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 G6355512132 Package HIBCC 10 In Commercial Distribution G635551213 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 Premarket exempt true 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 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
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