Tersus -14 BTK

GUDID 05391518030968

Tersus-14 BTK3520S 3.5mm x 20mm x 120cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic
Primary Device ID05391518030968
NIH Device Record Keyc3c1ca33-923f-44be-aae9-923c5c383e8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTersus -14 BTK
Version Model NumberBTK3520S
Company DUNS985021909
Company NameCREAGH MEDICAL 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

Device Dimensions

Length20 Millimeter
Outer Diameter3.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105391518030968 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [Tersus -14 BTK]

05391518031378Tersus-14 BTK40220L 4mm x 220mm x 150cm
05391518031361Tersus-14 BTK40150L 4mm x 150mm x 150cm
05391518031354Tersus-14 BTK40100L 4mm x 100mm x 150cm
05391518031347Tersus-14 BTK4080L 4mm x 80mm x 150cm
05391518031330Tersus-14 BTK4060L 4mm x 60mm x 150cm
05391518031323Tersus-14 BTK4020L 4mm x 20mm x 150cm
05391518031316Tersus-14 BTK35220L 3.5mm x 220mm x 150cm
05391518031309Tersus-14 BTK35150L 3.5mm x 150mm x 150cm
05391518031293Tersus-14 BTK35100L 3.5mm x 100mm x 150cm
05391518031286Tersus-14 BTK3580L 3.5mm x 80mm x 150cm
05391518031279Tersus-14 BTK3560L 3.5mm x 60mm x 150cm
05391518031262Tersus-14 BTK3520L 3.5mm x 20mm x 150cm
05391518031255Tersus-14 BTK30220L 3mm x 220mm x 150cm
05391518031248Tersus-14 BTK30150L 3mm x 150mm x 150cm
05391518031231Tersus-14 BTK30100L 3mm x 100mm x 150cm
05391518031224Tersus-14 BTK3080L 3mm x 80mm x 150cm
05391518031217Tersus-14 BTK3060L 3mm x 60mm x 150cm
05391518031200Tersus-14 BTK3020L 3mm x 20mm x 150cm
05391518031194Tersus-14 BTK25220L 2.5mm x 220mm x 150cm
05391518031187Tersus-14 BTK25150L 2.5mm x 150mm x 150cm
05391518031170Tersus-14 BTK25100L 2.5mm x 100mm x 150cm
05391518031163Tersus-14 BTK2580L 2.5mm x 80mm x 150cm
05391518031156Tersus-14 BTK2560L 2.5mm x 60mm x 150cm
05391518031149Tersus-14 BTK2520L 2.5mm x 20mm x 150cm
05391518031132Tersus-14 BTK20220L 2mm x 220mm x 150cm
05391518031125Tersus-14 BTK20150L 2mm x 150mm x 150cm
05391518031118Tersus-14 BTK20100L 2mm x 100mm x 150cm
05391518031101Tersus-14 BTK2080L 2mm x 80mm x 150cm
05391518031095Tersus-14 BTK2060L 2mm x 60mm x 150cm
05391518031088Tersus-14 BTK2020L 2mm x 20mm x 150cm
05391518031071Tersus-14 BTK40220S 4mm x 220mm x 120cm
05391518031064Tersus-14 BTK40150S 4mm x 150mm x 120cm
05391518031057Tersus-14 BTK40100S 4mm x 100mm x 120cm
05391518031040Tersus-14 BTK4080S 4mm x 80mm x 120cm
05391518031033Tersus-14 BTK4060S 4mm x 60mm x 120cm
05391518031026Tersus-14 BTK4020S 4mm x 20mm x 120cm
05391518031019Tersus-14 BTK35220S 3.5mm x 220mm x 120cm
05391518031002Tersus-14 BTK35150S 3.5mm x 150mm x 120cm
05391518030999Tersus-14 BTK35100S 3.5mm x 100mm x 120cm
05391518030982Tersus-14 BTK3580S 3.5mm x 80mm x 120cm
05391518030975Tersus-14 BTK3560S 3.5mm x 60mm x 120cm
05391518030968Tersus-14 BTK3520S 3.5mm x 20mm x 120cm
05391518030951Tersus-14 BTK30220S 3mm x 220mm x 120cm
05391518030944Tersus-14 BTK30150S 3mm x 150mm x 120cm
05391518030937Tersus-14 BTK30100S 3mm x 100mm x 120cm
05391518030920Tersus-14 BTK3080S 3mm x 80mm x 120cm
05391518030913Tersus-14 BTK3060S 3mm x 60mm x 120cm
05391518030906Tersus-14 BTK3020S 3mm x 20mm x 120cm
05391518030890Tersus-14 BTK25220S 2.5mm x 220mm x 120cm
05391518030883Tersus-14 BTK25150S 2.5mm x 150mm x 120cm

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