Identity
- Trade Name
- Iliderm Rx Skin Emulsion FDA UDI
- Generic Name
- Skin osmotic dressing, non-sterile FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- D0005 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850016143112 FDA UDI
- 510(k) Number
- K141637 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Skin osmotic dressing, non-sterile FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Skin osmotic dressing, non-sterile
Iliderm Rx Skin Emulsion by Levins Pharmaceuticals LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin osmotic dressing, non-sterile.
Cleared under the same submission
K141637 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Levins Pharmaceuticals LLC
Sources (1)
- FDA UDI ec335a00-35f8-406f-871e-34bcdd48d308 35 fields · synced May 30, 2026