Cronus™ HP - OTW PTA BALLOON CATHETER

GUDID 00383790003971

OTW High Pressure Peripheral Balloon Catheter

NIPRO MEDICAL CORPORATION

Peripheral angioplasty balloon catheter, basic
Primary Device ID00383790003971
NIH Device Record Key9a8cfae0-1d3a-4f00-920e-36511d8035e1
Commercial Distribution Discontinuation2020-01-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCronus™ HP - OTW PTA BALLOON CATHETER
Version Model NumberNCH+73045
Company DUNS797372554
Company NameNIPRO MEDICAL CORPORATION
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (908) 393-7030
Emailinfo@nipromed.com
Phone+1 (908) 393-7030
Emailinfo@nipromed.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100383790003971 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-30
Device Publish Date2016-09-16

On-Brand Devices [Cronus™ HP - OTW PTA BALLOON CATHETER]

00383790004350OTW High Pressure Peripheral Balloon Catheter
00383790004343OTW High Pressure Peripheral Balloon Catheter
00383790004336OTW High Pressure Peripheral Balloon Catheter
00383790004329OTW High Pressure Peripheral Balloon Catheter
00383790004312OTW High Pressure Peripheral Balloon Catheter
00383790004305OTW High Pressure Peripheral Balloon Catheter
00383790004299OTW High Pressure Peripheral Balloon Catheter
00383790004282OTW High Pressure Peripheral Balloon Catheter
00383790004275OTW High Pressure Peripheral Balloon Catheter
00383790004268OTW High Pressure Peripheral Balloon Catheter
00383790004251OTW High Pressure Peripheral Balloon Catheter
00383790004244OTW High Pressure Peripheral Balloon Catheter
00383790004237OTW High Pressure Peripheral Balloon Catheter
00383790004220OTW High Pressure Peripheral Balloon Catheter
00383790004213OTW High Pressure Peripheral Balloon Catheter
00383790004206OTW High Pressure Peripheral Balloon Catheter
00383790004190OTW High Pressure Peripheral Balloon Catheter
00383790004183OTW High Pressure Peripheral Balloon Catheter
00383790004008OTW High Pressure Peripheral Balloon Catheter
00383790003995OTW High Pressure Peripheral Balloon Catheter
00383790003988OTW High Pressure Peripheral Balloon Catheter
00383790003971OTW High Pressure Peripheral Balloon Catheter
00383790003964OTW High Pressure Peripheral Balloon Catheter
00383790003957OTW High Pressure Peripheral Balloon Catheter
00383790003803OTW High Pressure Peripheral Balloon Catheter
00383790003797OTW High Pressure Peripheral Balloon Catheter
00383790003780OTW High Pressure Peripheral Balloon Catheter
00383790003773OTW High Pressure Peripheral Balloon Catheter
00383790003766OTW High Pressure Peripheral Balloon Catheter
00383790003759OTW High Pressure Peripheral Balloon Catheter
00383790003742OTW High Pressure Peripheral Balloon Catheter
00383790003735OTW High Pressure Peripheral Balloon Catheter
00383790003728OTW High Pressure Peripheral Balloon Catheter
00383790003711OTW High Pressure Peripheral Balloon Catheter
00383790003704OTW High Pressure Peripheral Balloon Catheter
00383790003698OTW High Pressure Peripheral Balloon Catheter
00383790003681OTW High Pressure Peripheral Balloon Catheter
00383790003674OTW High Pressure Peripheral Balloon Catheter
00383790003605OTW High Pressure Peripheral Balloon Catheter
00383790003599OTW High Pressure Peripheral Balloon Catheter
00383790003582OTW High Pressure Peripheral Balloon Catheter
00383790003575OTW High Pressure Peripheral Balloon Catheter
00383790003568OTW High Pressure Peripheral Balloon Catheter
00383790003551OTW High Pressure Peripheral Balloon Catheter
00383790003544OTW High Pressure Peripheral Balloon Catheter
00383790003537OTW High Pressure Peripheral Balloon Catheter
00383790003520OTW High Pressure Peripheral Balloon Catheter
00383790003513OTW High Pressure Peripheral Balloon Catheter
00383790003506OTW High Pressure Peripheral Balloon Catheter
00383790003407OTW High Pressure Peripheral Balloon Catheter

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