Duns Number:175899459
Device Description: IMPAD RIGID SOLE FOOT COVER PAIR (1 EACH OF RIGHT AND LEFT)
Catalog Number
KEN5075
Brand Name
NA
Version/Model Number
KEN5075
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012597,K012597
Product Code
JOW
Product Code Name
SLEEVE, LIMB, COMPRESSIBLE
Public Device Record Key
6ce61564-56bf-49ee-9b19-044e5e9071d5
Public Version Date
August 14, 2019
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
20888551042106
Quantity per Package
5
Contains DI Package
10888551042109
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2763 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1372 |
| U | Unclassified | 20 |