Cure Pocket XL™

GUDID 20815947020738

Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Straight Tip

CURE MEDICAL LLC

Single-administration urethral drainage catheter
Primary Device ID20815947020738
NIH Device Record Keyd6b422c2-b95c-498f-ac39-d8ce65c0ae20
Commercial Distribution StatusIn Commercial Distribution
Brand NameCure Pocket XL™
Version Model NumberM12XL
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

Length25 Inch
Length25 Inch
Length25 Inch
Length25 Inch
Length25 Inch
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch
Catheter Gauge12 French
Length25 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100815947020734 [Primary]
GS110815947020731 [Package]
Contains: 00815947020734
Package: Box [30 Units]
In Commercial Distribution
GS120815947020738 [Package]
Contains: 10815947020731
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

EZDCatheter, Straight

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 Pocket XL™]

20815947020813Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Coudé Tip
20815947020806Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Coudé Tip
20815947020790Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Coudé Tip
20815947020783Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Coudé Tip
00815947020772Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Coudé Tip
20815947020769Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Straight Tip
20815947020752Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Straight Tip
20815947020745Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Straight Tip
20815947020738Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Straight Tip
20815947020721Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Straight Tip
00815947020710Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Straight Tip

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