Home GUDID 07350031350838 Bonopty Biopsy Set
Primary DI 07350031350838
Brand Bonopty Biopsy Set
Company Apriomed AB
Model 10-1083
Catalog number 10-1083
Device description Manually operated, sterile, single use coaxial bone biopsy system
Published 2020-12-04
Public version status Update
Distribution status Not 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 GAA Needle, Aspiration And Injection, Disposable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17350031350835 Package GS1 5 Not in Commercial Distribution 27350031350832 Package GS1 12 Not in Commercial Distribution 07350031350838 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17350031350835 17350031350835 27350031350832 27350031350832 07350031350838 07350031350838 7350031350838
GMDN Terms# Term, Definition table Term Definition Bone biopsy needle A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone, bone marrow and/or tumour from any bone of the body. It is typically inserted through a bone access cannula under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and supplied with an ejector rod to remove the biopsy. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 19.5 Centimeter Needle Gauge 15 Gauge
Regulatory Flags# DUNS number 631734758 Device count 1 Premarket exempt true 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 07350031350623 Bonopty Penetration Set 10-1062 10-1062 2020-12-02 07350031350630 Bonopty Biopsy Set 10-1063 10-1063 2020-12-01 07350031350722 Bonopty Penetration Set 10-1072 10-1072 2020-12-04 07350031350739 Bonopty Biopsy Set 10-1073 10-1073 2020-12-04 07350031350746 Bonopty Extended Drill 10-1074 10-1074 2020-12-04 07350031350821 Bonopty Penetration Set 10-1082 10-1082 2020-12-04 07350031351194 Gangi-SoftGuard Coaxial Needle SG12-121 SG12-121 2019-01-21 07350031351217 Gangi-SoftGuard Coaxial Needle SG13-071 SG13-071 2019-01-21 07350031351224 Gangi-SoftGuard Coaxial Needle SG13-121 SG13-121 2019-01-21 07350031351231 Gangi-SoftGuard Coaxial Needle SG13-171 SG13-171 2019-01-21 07350031351248 Gangi-SoftGuard Coaxial Needle SG15-071 SG15-071 2019-01-21 07350031351255 Gangi-SoftGuard Coaxial Needle SG15-121 SG15-121 2019-01-21 07350031351262 Gangi-SoftGuard Coaxial Needle SG15-171 SG15-171 2019-01-21 07350031351279 Gangi-SoftGuard Coaxial Needle SG17-071 SG17-071 2019-01-21 07350031351286 Gangi-SoftGuard Coaxial Needle SG17-121 SG17-121 2019-01-21 07350031351293 Gangi-SoftGuard Coaxial Needle SG17-171 SG17-171 2019-01-21 07350031351330 Gangi-HydroGuard Coaxial Needle HG15-121 HG15-121 2019-01-21 07350031351347 Gangi-HydroGuard Coaxial Needle HG15-171 HG15-171 2019-01-21 07350031351354 Gangi-HydroGuard Coaxial Needle HG17-121 HG17-121 2019-01-21 07350031351361 Gangi-HydroGuard Coaxial Needle HG17-171 HG17-171 2019-01-21
Other Devices Sharing Product Codes# 
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