Duns Number:070637129
Device Description: These male external catheters are commonly referred to as a “Molded-Latex” style because t These male external catheters are commonly referred to as a “Molded-Latex” style because they are dipped from a single piece of latex without seams rather than assembled from multiple components. Each Uro-Cath® catheter has a thin, latex sheath section similar to a condom at one end—the part that is rolled over the head and shaft of the penis—and a heavier funnel-shaped, cup section at the other—where urine is drained from into a bag or other collection device—making them virtually “twist-proof” by their unique design. Uro-Cath® catheters range in size from 25mm, our smallest, to 40mm, 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-Cath® Male External Catheter,1 Urofoam®-2 Double-Sided Adhesive Foam Strip,Illustrated, application instructions on back of pouch/package
Catalog Number
522135
Brand Name
Uro-Cath® Molded-Latex Male External Catheter, Large 35mm with Urofoam®-2
Version/Model Number
522135
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
b446db43-3006-47a3-98e6-8ebe00f88be2
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 30, 2018
Package DI Number
10792293221350
Quantity per Package
50
Contains DI Package
00792293221353
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 |