Home GUDID 00857141005018 OptionELITE Vena Cava Filter, 100cm
Primary DI 00857141005018
Brand OptionELITE Vena Cava Filter, 100cm
Company Rex Medical LLP
Model 352506100E
Catalog number 352506100E
Published 2015-12-07
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DTK Filter, Intravascular, Cardiovascular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DTK Filter, Intravascular, Cardiovascular Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00857141005018 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00857141005018 00857141005018 857141005018 0857141005018
GMDN Terms# Term, Definition table Term Definition Vena cava filter, temporary/permanent A vascular device intended to be percutaneously implanted in the inferior vena cava (IVC) to prevent pulmonary embolism (PE); it can be retrieved before a threshold period or remain as a permanent implant after the period. It achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding designs (e.g., conical, basket). This is a single-use device.
Regulatory Flags# DUNS number 079535216 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 false 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 00857141005261 Quadra-Fuse Multi-Pronged Injection Needle 4218-10SS 4218-10SS 2020-12-07 00857141005278 Quadra-Fuse Multi-Pronged Injection Needle 4218-15SS 4218-15SS 2020-12-07 00857141005285 Quadra-Fuse Multi-Pronged Injection Needle 4218-20SS 4218-20SS 2020-12-07 00857141005292 Quadra-Fuse Multi-Pronged Injection Needle 4518-20SS 4518-20SS 2020-12-07 00857141005308 Quadra-Fuse Multi-Pronged Injection Needle 4518-15SS 4518-15SS 2020-12-07 00857141005315 Quadra-Fuse Multi-Pronged Injection Needle 4518-10SS 4518-10SS 2020-12-07 00857141005001 OptionELITE Vena Cava Filter 352506070E 352506070E 2015-12-07 10857141005251 Closer Vascular Sealing System 202704 202704 2017-03-28
Other Devices Sharing Product Codes# 
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