Home GUDID 05407005000076 Spirotome
Primary DI 05407005000076
Brand Spirotome
Company Bioncise
Model SS1015
Catalog number SS1015
Device description The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissu
Published 2018-08-31
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05407005000076 Package GS1 5 In Commercial Distribution 05407005001073 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05407005000076 05407005000076 5407005000076 05407005001073 05407005001073 5407005001073
GMDN Terms# Term, Definition table Term Definition Soft-tissue biopsy needle, single-use A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for hsitopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.
Regulatory Flags# DUNS number 371402316 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number true Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company#