Sleek OTW PTA Dilatation Catheter 426-4028X

GUDID 00801741133954

Sleek OTW PTA Dilatation Catheter 4.0mm x 280mm balloon, 150cm shaft

CLEARSTREAM TECHNOLOGIES LIMITED

Peripheral angioplasty balloon catheter, basic
Primary Device ID00801741133954
NIH Device Record Key1b6c255e-a0f4-4b0c-b7c5-12c40d76cdb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleek OTW PTA Dilatation Catheter
Version Model Number426-4028X
Catalog Number426-4028X
Company DUNS989214291
Company NameCLEARSTREAM TECHNOLOGIES LIMITED
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.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
GS100801741133954 [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 Number4
Public Version Date2019-08-09
Device Publish Date2016-09-16

On-Brand Devices [Sleek OTW PTA Dilatation Catheter]

00801741134036Sleek OTW PTA Dilatation Catheter 5.0mm x 280mm balloon, 150cm shaft
00801741134029Sleek OTW PTA Dilatation Catheter 5.0mm x 220mm balloon, 150cm shaft
00801741134012Sleek OTW PTA Dilatation Catheter 5.0mm x 150mm balloon, 150cm shaft
00801741134005Sleek OTW PTA Dilatation Catheter 5.0mm x 120mm balloon, 150cm shaft
00801741133992Sleek OTW PTA Dilatation Catheter 5.0mm x 100mm balloon, 150cm shaft
00801741133985Sleek OTW PTA Dilatation Catheter 5.0mm x 80mm balloon, 150cm shaft
00801741133978Sleek OTW PTA Dilatation Catheter 5.0mm x 40mm balloon, 150cm shaft
00801741133961Sleek OTW PTA Dilatation Catheter 5.0mm x 20mm balloon, 150cm shaft
00801741133954Sleek OTW PTA Dilatation Catheter 4.0mm x 280mm balloon, 150cm shaft
00801741133947Sleek OTW PTA Dilatation Catheter 4.0mm x 220mm balloon, 150cm shaft
00801741133930Sleek OTW PTA Dilatation Catheter 4.0mm x 150mm balloon, 150cm shaft
00801741133923Sleek OTW PTA Dilatation Catheter 4.0mm x 120mm balloon, 150cm shaft
00801741133916Sleek OTW PTA Dilatation Catheter 4.0mm x 100mm balloon, 150cm shaft
00801741133909Sleek OTW PTA Dilatation Catheter 4.0mm x 80mm balloon, 150cm shaft
00801741133893Sleek OTW PTA Dilatation Catheter 4.0mm x 40mm balloon, 150cm shaft
00801741133886Sleek OTW PTA Dilatation Catheter 4.0mm x 20mm balloon, 150cm shaft
00801741133879Sleek OTW PTA Dilatation Catheter 3.5mm x 280mm balloon, 150cm shaft
00801741133862Sleek OTW PTA Dilatation Catheter 3.5mm x 220mm balloon, 150cm shaft
00801741133855Sleek OTW PTA Dilatation Catheter 3.5mm x 150mm balloon, 150cm shaft
00801741133848Sleek OTW PTA Dilatation Catheter 3.5mm x 120mm balloon, 150cm shaft
00801741133831Sleek OTW PTA Dilatation Catheter 3.5mm x 100mm balloon, 150cm shaft
00801741133824Sleek OTW PTA Dilatation Catheter 3.5mm x 80mm balloon, 150cm shaft
00801741133817Sleek OTW PTA Dilatation Catheter 3.5mm x 40mm balloon, 150cm shaft
00801741133800Sleek OTW PTA Dilatation Catheter 3.5mm x 20mm balloon, 150cm shaft
00801741133794Sleek OTW PTA Dilatation Catheter 3.0mm x 280mm balloon, 150cm shaft
00801741133787Sleek OTW PTA Dilatation Catheter 3.0mm x 220mm balloon, 150cm shaft
00801741133770Sleek OTW PTA Dilatation Catheter 3.0mm x 150mm balloon, 150cm shaft
00801741133763Sleek OTW PTA Dilatation Catheter 3.0mm x 120mm balloon, 150cm shaft
00801741133756Sleek OTW PTA Dilatation Catheter 3.0mm x 100mm balloon, 150cm shaft
00801741133749Sleek OTW PTA Dilatation Catheter 3.0mm x 80mm balloon, 150cm shaft
00801741133732Sleek OTW PTA Dilatation Catheter 3.0mm x 40mm balloon, 150cm shaft
00801741133725Sleek OTW PTA Dilatation Catheter 3.0mm x 20mm balloon, 150cm shaft
00801741133718Sleek OTW PTA Dilatation Catheter 2.5mm x 280mm balloon, 150cm shaft
00801741133701Sleek OTW PTA Dilatation Catheter 2.5mm x 220mm balloon, 150cm shaft
00801741133695Sleek OTW PTA Dilatation Catheter 2.5mm x 150mm balloon, 150cm shaft
00801741133688Sleek OTW PTA Dilatation Catheter 2.5mm x 120mm balloon, 150cm shaft
00801741133671Sleek OTW PTA Dilatation Catheter 2.5mm x 100mm balloon, 150cm shaft
00801741133664Sleek OTW PTA Dilatation Catheter 2.5mm x 80mm balloon, 150cm shaft
00801741133657Sleek OTW PTA Dilatation Catheter 2.5mm x 40mm balloon, 150cm shaft
00801741133640Sleek OTW PTA Dilatation Catheter 2.5mm x 20mm balloon, 150cm shaft
00801741133633Sleek OTW PTA Dilatation Catheter 2.0mm x 280mm balloon, 150cm shaft
00801741133626Sleek OTW PTA Dilatation Catheter 2.0mm x 220mm balloon, 150cm shaft
00801741133619Sleek OTW PTA Dilatation Catheter 2.0mm x 150mm balloon, 150cm shaft
00801741133602Sleek OTW PTA Dilatation Catheter 2.0mm x 120mm balloon, 150cm shaft
00801741133596Sleek OTW PTA Dilatation Catheter 2.0mm x 100mm balloon, 150cm shaft
00801741133589Sleek OTW PTA Dilatation Catheter 2.0mm x 80mm balloon, 150cm shaft
00801741133572Sleek OTW PTA Dilatation Catheter 2.0mm x 40mm balloon, 150cm shaft
00801741133565Sleek OTW PTA Dilatation Catheter 2.0mm x 20mm balloon, 150cm shaft
00801741133558Sleek OTW PTA Dilatation Catheter 1.5mm x 120mm balloon, 150cm shaft
00801741133541Sleek OTW PTA Dilatation Catheter 1.5mm x 100mm balloon, 150cm shaft

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