Duns Number:397310355
Device Description: A 2-layer reduced multicomponent compression bandage system, composed of a short stretch b A 2-layer reduced multicomponent compression bandage system, composed of a short stretch bandage and a long stretch bandage.Layer 1, KTECH Lite/KTECH Reduced composition: wadding: viscose, polyester; knitted layer: polyamide, elastane.Layer 2, KPRESS composition: cotton, polyester, polyamide, elastane; synthetic latex free cohesive material.
Catalog Number
-
Brand Name
URGOK2 LITE
Version/Model Number
553246
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
327ee719-3413-4c55-abc6-fb959e86998b
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
April 26, 2021
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 | 15 |
| U | Unclassified | 5 |