Home GUDID 4042301159960 Nit-Occlud PDA
Primary DI 4042301159960
Brand Nit-Occlud PDA
Company pfm medical ag
Model 145054V2
Device description Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.
Published 2014-08-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MAE Occluder, Patent Ductus, Arteriosus
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAE Occluder, Patent Ductus, Arteriosus Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 4042301159960 Package GS1 10 In Commercial Distribution 04042301159953 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 4042301159960 04042301159960 4042301159960 04042301159953 04042301159953 4042301159953
GMDN Terms# Term, Definition table Term Definition Cardiac occluder An implantable disk-like device intended for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) an atrial septal defect (ASD), a ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA).
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 316661214 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 false 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 From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05415067030979 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067030986 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067030993 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031006 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031013 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031020 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031037 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031044 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031051 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 00811806011189 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-19 00811806011202 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011219 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011233 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011240 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011257 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011264 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011103 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-08 00811806011110 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-08 00811806011127 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-08 00811806011134 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-08 00811806011141 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-08 00811806011172 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-08 04042301159953 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 04042301159977 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 04042301159991 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 04042301160010 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 04042301160034 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 04042301159939 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 4042301159984 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 4042301160003 Nit-Occlud PDA pfm medical ag MAE 2014-08-06
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