Identity
- Trade Name
- Aladerm Plus FDA UDI
- Generic Name
- Skin osmotic dressing, non-antimicrobial FDA UDI
- Device Name
- Topical skin care emulsion FDA UDI
- Model / Reference
- 282 FDA UDI
- Description
- Topical skin care emulsion FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00328595282022 FDA UDI
- 510(k) Number
- K141637 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Skin osmotic dressing, non-antimicrobial 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
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 60 Milliliter FDA UDI
Category: Skin osmotic dressing, non-antimicrobial
Aladerm Plus by Allegis Pharmaceuticals, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin osmotic dressing, non-antimicrobial.
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
- Allegis Pharmaceuticals, LLC
Sources (1)
- FDA UDI c1582baf-e5dd-436d-8bcc-c113e65a8efd 36 fields · synced May 30, 2026