Duns Number:052758618
Device Description: URGOK2 is a two layer compression system including KTECH: a white, short-stretch bandage; URGOK2 is a two layer compression system including KTECH: a white, short-stretch bandage; providing compression, protection and absorbency and KPRESS: a cohesive long-stretch bandage providing the additional compression necessary to achieve therapeutic pressure and secure the bandages in place.URGOK2 is for the treatment of venous leg ulcer, venous edema and lymphedema, which require full compression.Not made with natural rubber latex.
Catalog Number
553244
Brand Name
URGOK2
Version/Model Number
553244
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
5b1ef689-6db2-469f-b9b8-48c3ff60ff3c
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
December 20, 2019
Package DI Number
10190769532441
Quantity per Package
27
Contains DI Package
00190769532444
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 12 |