Cure Ultra Male Catheter

GUDID 20815947021032

Sterile Intermittent Catheter, Straight Tip

CURE MEDICAL LLC

Single-administration urethral drainage catheter
Primary Device ID20815947021032
NIH Device Record Key27fd2c95-27ef-4be1-b25c-7517ceb9fe22
Commercial Distribution StatusIn Commercial Distribution
Brand NameCure Ultra Male Catheter
Version Model NumberULTRA M8
Company DUNS070643426
Company NameCURE MEDICAL LLC
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com
Phone+18004228811
Emailcic@convatec.com

Device Dimensions

Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Length16 Inch
Catheter Gauge8 French
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100815947021038 [Primary]
GS110815947021035 [Package]
Contains: 00815947021038
Package: Box [30 Units]
In Commercial Distribution
GS120815947021032 [Package]
Contains: 10815947021035
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KODCatheter, Urological

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 Date2017-04-07

On-Brand Devices [Cure Ultra Male Catheter]

20815947021087Sterile Intermittent Catheter, Straight Tip
20815947021070Sterile Intermittent Catheter, Straight Tip
20815947021063Sterile Intermittent Catheter, Straight Tip
20815947021056Sterile Intermittent Catheter, Straight Tip
20815947021049Sterile Intermittent Catheter, Straight Tip
20815947021032Sterile Intermittent Catheter, Straight Tip

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.