FDA UDI
In Commercial Distribution
🇺🇸 United States
Derma-R Cream
DI: 00382098010506
·
Model: 1
·
Raya Pharmaceuticals LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Derma-R Cream
- Primary DI
- 00382098010506
- Version / Model
- 1
- Company Name
- Raya Pharmaceuticals LLC
- Labeler DUNS
- 106631637
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-29
- Public Version
- 1
- Public Version Date
- 2024-11-06
- Public Version Status
- New
- Public Device Record Key
- 9e02130d-d22e-4d2e-963d-62d066d4efcb
Device Description
Derma-R Cream is a non-sterile formulation intended for topical application. It is intended for management of pruritus and Dryness of skin in Atopic dermatitis and Allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46206 | Dry skin moisture barrier dressing | A substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382098010506 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240722 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius