Home GUDID 08052286590036 Elesta - Introducer
Primary DI 08052286590036
Brand Elesta - Introducer
Company ELESTA SRL
Model CH2120. 6EC
Device description CHIBA Introducer needle, 21Gx20.6 cm
Published 2019-04-23
Public version status Update
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 GAA Needle, Aspiration And Injection, Disposable GDF Guide, Needle, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery 1 GDF Guide, Needle, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08052286590036 Package GS1 20 In Commercial Distribution 08052286590012 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08052286590036 08052286590036 8052286590036 08052286590012 08052286590012 8052286590012
GMDN Terms# Term, Definition table Term Definition Interventional radiology percutaneous-access procedure kit A collection of various sterile radiopaque instruments/devices (e.g., introducer sheath, dilator, needle, angiographic catheter) intended to be used for image-guided, single-puncture, percutaneous access to facilitate an interventional radiology procedure (e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures). It does not contain pharmaceuticals. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 206 Millimeter Needle Gauge 21 Gauge
Regulatory Flags# DUNS number 895683282 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 true Sterilization required before use false Other Devices Sharing Product Codes#