Duns Number:052758618
Device Description: URGOK2 Lite is a two layer Compression System which includes KTECH Lite: a white, short-s URGOK2 Lite is a two layer Compression System which includes KTECH Lite: 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 Lite is for the treatment of venous or mixed leg ulcers, venous edema and lymphedema, which require reduced level of compression.Not made with natural rubber latex.
Catalog Number
553245
Brand Name
URGOK2 Lite
Version/Model Number
553245
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
d674f56c-40cb-48ec-ae42-09c24e55e312
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
December 20, 2019
Package DI Number
10190769532458
Quantity per Package
21
Contains DI Package
00190769532451
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 |