Dynamis AV

GUDID 05391525783307

Dynamis PTA UHP 8mm x 60mm x 75cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic
Primary Device ID05391525783307
NIH Device Record Keybf548575-c9ca-47a1-a3e0-266bc21eb626
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynamis AV
Version Model NumberD0806062375
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

Outer Diameter8 Millimeter
Length60 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105391525783307 [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 Date2018-09-28
Device Publish Date2018-08-28

On-Brand Devices [Dynamis AV]

05391525783369Dynamis PTA UHP 16mm x 40mm x 75cm
05391525783352Dynamis PTA UHP 14mm x 40mm x 75cm
05391525783345Dynamis PTA UHP 12mm x 40mm x 75cm
05391525783338Dynamis PTA UHP 10mm x 40mm x 75cm
05391525783321Dynamis PTA UHP 9mm x 40mm x 75cm
05391525783314Dynamis PTA UHP 8mm x 80mm x 75cm
05391525783307Dynamis PTA UHP 8mm x 60mm x 75cm
05391525783291Slimline Dynamis PTA UHP 8mm x 40mm x 75cm
05391525783284Dynamis PTA UHP 8mm x 40mm x 75cm
05391525783277Dynamis PTA UHP 8mm x 20mm x 75cm
05391525783260Dynamis PTA UHP 7mm x 100mm x 75cm
05391525783253Dynamis PTA UHP 7mm x 60mm x 75cm
05391525783246Slimline Dynamis PTA UHP 7mm x 40mm x 75cm
05391525783239Dynamis PTA UHP 7mm x 40mm x 75cm
05391525783222Dynamis PTA UHP 7mm x 20mm x 75cm
05391525783215Dynamis PTA UHP 6mm x 100mm x 75cm
05391525783208Dynamis PTA UHP 6mm x 40mm x 75cm
05391525783192Dynamis PTA UHP 6mm x 20mm x 75cm
05391525783185Dynamis PTA UHP 5mm x 40mm x 75cm
05391525783178Dynamis PTA UHP 5mm x 20mm x 75cm
05391525783161Dynamis PTA UHP 4mm x 40mm x 75cm
05391525783154Dynamis PTA UHP 4mm x 20mm x 75cm
05391525783147Dynamis PTA UHP 3mm x 40mm x 75cm

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