Identity
- Trade Name
- Neosalus Cream FDA UDI
- Generic Name
- Dry skin moisture barrier dressing FDA UDI
- Device Name
- NEOSALUS Cream is a fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Cream is intended for topical application. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- NEOSALUS Cream is a fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Cream is intended for topical application. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00381811000008 FDA UDI
- 510(k) Number
- K090585 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Dry skin moisture barrier dressing 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
No
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
Dimensions & Sizes
- Size
- Weight — 100 Gram FDA UDI
Category: Dry skin moisture barrier dressing
Neosalus Cream by Resilia Pharmaceuticals, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dry skin moisture barrier dressing.
- Halyard — O&M HALYARD, INC. · Class I
- Vaseline — Cardinal Health 200, LLC · U
- GlucanPro — Stellen Medical, LLC · U
- Karaya 5 — Hollister Incorporated · Class I
- GlucanPro 3000 — Stellen Medical, LLC · U
- Dash Topic — AIM MEDICAL INC · U
- Vaseline — Cardinal Health 200, LLC · U
- Dash Topic — AIM MEDICAL INC · U
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Resilia Pharmaceuticals, Inc.
Sources (1)
- FDA UDI cd91d319-d952-40b9-acca-6b39f1562472 37 fields · synced May 30, 2026