Duns Number:070637129
Device Description: These male external catheters are commonly referred to as a “Texas-Style” because they emp These male external catheters are commonly referred to as a “Texas-Style” because they employ a three-piece construction technique. Each Uro-Con® catheter has a thin, latex sheath similar to a condom—which is rolled over the head and shaft of the penis—and is attached to a 4"(10cm) or 2"(5cm) white-rubber tube—where urine is drained from into a bag or other collection device—by an plastic catheter insert. Using a “Condom” type sheath makes these catheters “fully collapsible” to prevent pooled urine a major cause of skin irritation and break-down. Uro-Con® catheters range in size from 25mm, our smallest, to 35mm, our largest in 5mm increments to suit a variety of individual requirements. They are packaged individually in a window pouch allowing for quick, easy product identification without opening the pouch. The back side of the pouch contains detailed, illustrated, application instructions relative to the product purchasedContains:1 Uro-Con® Male External Catheter,1 Urofoam®-1 Single-Sided Adhesive Foam Strip,Illustrated, application instructions on back of pouch/package
Catalog Number
511425
Brand Name
Uro-Con® Texas-Style Male External Catheter, Small 25mm 4" Tube with Urofoam®-1
Version/Model Number
511425
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NNX
Product Code Name
Device, Incontinence, Urosheath Type, Non-Sterile
Public Device Record Key
cac42c04-9849-4007-83ba-744c33fe6168
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 30, 2018
Package DI Number
10792293114256
Quantity per Package
50
Contains DI Package
00792293114259
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 140 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |