Cure Ultra Catheter

GUDID 20815947020417

Sterile Female Intermittent Catheter, Straight Tip

CURE MEDICAL LLC

Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter
Primary Device ID20815947020417
NIH Device Record Keyd5e88377-b532-47dd-830f-33a5f5017d4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCure Ultra Catheter
Version Model NumberULTRA8
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

Device Dimensions

Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100815947020413 [Primary]
GS110815947020410 [Package]
Contains: 00815947020413
Package: Box [30 Units]
In Commercial Distribution
GS120815947020417 [Package]
Contains: 10815947020410
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 Date2016-09-24

On-Brand Devices [Cure Ultra Catheter]

20815947020455Sterile Female Intermittent Catheter, Straight Tip
20815947020448Sterile Female Intermittent Catheter, Straight Tip
20815947020431Sterile Female Intermittent Catheter, Straight Tip
20815947020424Sterile Female Intermittent Catheter, Straight Tip
20815947020417Sterile Female Intermittent Catheter, Straight Tip

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