Cure Twist®

GUDID 20815947020516

Twist Sterile Female Catheter with Insertion Kit, Straight Tip

CURE MEDICAL LLC

Single-administration urethral catheterization kit, single-use
Primary Device ID20815947020516
NIH Device Record Key2d923538-2a42-4658-9c3c-57170bb7e04a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCure Twist®
Version Model NumberT14K
Company DUNS070643426
Company NameCURE MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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

Device Dimensions

Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
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Catheter Gauge14 French
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Catheter Gauge14 French
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Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter
Catheter Gauge14 French
Length15 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100815947020512 [Primary]
GS110815947020519 [Package]
Contains: 00815947020512
Package: Box [30 Units]
In Commercial Distribution
GS120815947020516 [Package]
Contains: 10815947020519
Package: Case [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
OHRCatheter Care Tray

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 Twist®]

20815947020974Twist Sterile Female Catheter with Insertion Kit, Straight Tip
20815947020967Twist Sterile Female Catheter with Insertion Kit, Straight Tip
20815947020950Twist Sterile Female Catheter with Insertion Kit, Straight Tip
20815947020943Twist Sterile Female Catheter with Insertion Kit, Straight Tip
20815947020516Twist Sterile Female Catheter with Insertion Kit, Straight Tip
20815947020400Twist Sterile Female Intermittent Catheter, Straight Tip
20815947020394Twist Sterile Female Intermittent Catheter, Straight Tip
20815947020387Twist Sterile Female Intermittent Catheter, Straight Tip
20815947020370Twist Sterile Female Intermittent Catheter, Straight Tip
00815947020369Twist Sterile Female Intermittent Catheter, Straight Tip

Trademark Results [Cure Twist]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CURE TWIST
CURE TWIST
85529741 4321921 Live/Registered
Cure Medical LLC
2012-01-31

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