JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW 5930-020-22

GUDID 06934955938016

Percutaneous Transluminal Angioplasty Balloon Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Peripheral angioplasty balloon catheter, basic
Primary Device ID06934955938016
NIH Device Record Key78230c36-e4b5-437f-87b7-7a9aa96296d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameJADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
Version Model Number5930-020-22
Catalog Number5930-020-22
Company DUNS530923226
Company NameOrbusNeich Medical (ShenZhen) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com
Phone13128973283
Emailgxia@orbusneich.com

Device Identifiers

Device Issuing AgencyDevice ID
GS106934955938016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, Angioplasty, Peripheral, Transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-05
Device Publish Date2024-07-27

On-Brand Devices [JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW]

06934955937415Percutaneous Transluminal Angioplasty Balloon Cathet
06934955937408Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937392Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937385Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937378Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937361Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937354Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937347Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937330Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937323Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937316Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937309Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937293Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937286Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937279Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937262Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937255Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937248Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937231Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937224Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937217Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937200Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937194Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937187Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937170Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937163Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937156Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937149Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937132Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937125Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937118Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937101Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937095Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937088Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937071Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937064Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937057Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937040Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937026Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937019Percutaneous Transluminal Angioplasty Balloon Catheter
06934955937002Percutaneous Transluminal Angioplasty Balloon Catheter
06934955936999Percutaneous Transluminal Angioplasty Balloon Catheter
06934955936982Percutaneous Transluminal Angioplasty Balloon Catheter
06934955936975Percutaneous Transluminal Angioplasty Balloon Catheter
06934955936968Percutaneous Transluminal Angioplasty Balloon Catheter
06934955936951Percutaneous Transluminal Angioplasty Balloon Catheter
06934955936944Percutaneous Transluminal Angioplasty Balloon Catheter
06934955936937Percutaneous Transluminal Angioplasty Balloon Catheter
06934955936920Percutaneous Transluminal Angioplasty Balloon Catheter
06934955936913Percutaneous Transluminal Angioplasty Balloon Catheter

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