Duns Number:070637129
Device Description: STRAP, FABRIC, MALE, EXTERNAL, CATHETER, UNIVERSAL, LATEX-FREE, VELCRO FASTENERS, REUSABLE STRAP, FABRIC, MALE, EXTERNAL, CATHETER, UNIVERSAL, LATEX-FREE, VELCRO FASTENERS, REUSABLEThe Uro-Strap® is an economical solution to numerous changes of tapes and adhesive strips. An elasticized cotton & loop construction allows the self-gripping fastener to attach itself anywhere along the length of the strap making it fully adjustable to individual requirements which provides security and aids in a comfortable fit.Contains:1 Fabric Catheter Strap,Use and Care Instructions
Catalog Number
6400
Brand Name
Uro-Strap® Fabric Universal Male External Catheter Strap 4.75"
Version/Model Number
6400
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
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
0f9727d4-6674-46dc-9a72-f066c55100c1
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 30, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |