Duns Number:809650005
Device Description: Epifoam Uncoated Pads (30 pads per case).
Catalog Number
EPFU-30
Brand Name
EPI-FOAM
Version/Model Number
EPFU-30
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K991604
Product Code
MDA
Product Code Name
Elastomer, Silicone, For Scar Management
Public Device Record Key
50f33e61-e278-40f1-8bb6-8db2fb2a15b5
Public Version Date
September 04, 2020
Public Version Number
1
DI Record Publish Date
August 27, 2020
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 | 182 |