DEVICE: Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm (00792293301246)
Device Identifier (DI) Information
Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm
530124
In Commercial Distribution
530124
UROCARE PRODUCTS, INC.
530124
In Commercial Distribution
530124
UROCARE PRODUCTS, INC.
These male external catheters are commonly referred to as a “Self-Adhering” style because they are contain an adhesive on the inside of the sheath which adheres to the skin when the catheter sheath is unrolled. Each Uro-Cath® II catheter has a thin, silicon 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. A retainer tray is provided to keep the catheters round shape while in storage. Uro-Cath® II catheters come in 24mm, 28mm, 31mm, 35mm and 40mm sizes 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 purchased–no “cookie-cutter” or “one fits all” instructions for all products like some similar products have. Once removed from the packaging and the retainer tray is removed, each catheter may be secured by simply unrolling the sheath over the shaft of the penis and firmly grasping around the shaft to ensure a secure fit for maximum comfort and security.
Contains:
1 Uro-Cath® II Male External Catheter,
Illustrated, application instructions on back of pouch/package.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
34929 | Urinary incontinence penis sheath/port, single-use |
A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NNX | Device, Incontinence, Urosheath Type, Non-Sterile |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dry place away from direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 24 Millimeter |
Device Size Text, specify: Small |
Weight: 0.015 Pound |
Device Record Status
f6c09437-073c-4589-9e51-203859938ee7
January 09, 2025
1
January 01, 2025
January 09, 2025
1
January 01, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
909-621-6013
CUST.SUPPORT@UROCARE.COM
CUST.SUPPORT@UROCARE.COM