Cure Dextra

GUDID 10815947021257

Closed System Single Urinary Catheterization System, Straight Tip

CURE MEDICAL LLC

Single-administration urethral drainage catheter
Primary Device ID10815947021257
NIH Device Record Keya6c8acb7-2121-453b-90b3-5187dc87346d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCure Dextra
Version Model NumberDEX14
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

Device Dimensions

Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French
Catheter Gauge14 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100815947021250 [Primary]
GS110815947021257 [Package]
Contains: 00815947021250
Package: Case [90 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-07
Device Publish Date2020-08-28

On-Brand Devices [Cure Dextra]

10815947021271Closed System Single Urinary Catheterization System, Straight Tip
10815947021264Closed System Single Urinary Catheterization System, Straight Tip
10815947021257Closed System Single Urinary Catheterization System, Straight Tip
00815947021243Closed System Single Urinary Catheterization System, Straight Tip
00815947021236Closed System Single Urinary Catheterization System, Straight Tip

Trademark Results [Cure Dextra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CURE DEXTRA
CURE DEXTRA
88489040 not registered Live/Pending
Cure Medical LLC
2019-06-25

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