Prolieve

GUDID B0638808260

Prolieve Thermodilatation Single Use Kit

Medifocus, Inc.

Microwave hyperthermia system
Primary Device IDB0638808260
NIH Device Record Keyeefe2379-a9c1-4e0a-b0b2-8d7bccf3dd57
Commercial Distribution StatusIn Commercial Distribution
Brand NameProlieve
Version Model NumberCoude Tip Catheter
Company DUNS828790159
Company NameMedifocus, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0638808260 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-09-09

On-Brand Devices [Prolieve]

B0638808260Prolieve Thermodilatation Single Use Kit
B0638808060Prolieve Thermodilatation System

Trademark Results [Prolieve]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROLIEVE
PROLIEVE
76563240 3055964 Live/Registered
MEDIFOCUS, INC.
2003-12-04

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