Millipede 088 Access Catheter MA088117US

GUDID 05391539370005

The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.

PERFUZE LIMITED

Vascular guide-catheter, single-use
Primary Device ID05391539370005
NIH Device Record Key1c14fe0c-2d36-4235-b0de-d773b171120e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMillipede 088 Access Catheter
Version Model Number1.1
Catalog NumberMA088117US
Company DUNS985715471
Company NamePERFUZE 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

Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch
Catheter Gauge8 French
Catheter Length115 Centimeter
Outer Diameter0.108 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS105391539370005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QJPCatheter, Percutaneous, Neurovasculature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-10
Device Publish Date2023-11-02

On-Brand Devices [Millipede 088 Access Catheter]

05391539370111The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) an
05391539370005The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) an
05391539370142The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) an
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