Duns Number:080839485
Device Description: Iliderm Rx Skin Emulsion is a water-based topical skin care emulsion that is indicated to Iliderm Rx Skin Emulsion is a water-based topical skin care emulsion that is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis.
Catalog Number
-
Brand Name
Iliderm Rx Skin Emulsion
Version/Model Number
D0005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141637
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
ec335a00-35f8-406f-871e-34bcdd48d308
Public Version Date
May 28, 2020
Public Version Number
1
DI Record Publish Date
May 20, 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 |
|---|---|---|
| U | Unclassified | 1 |