FDA UDI
In Commercial Distribution
🇺🇸 United States
Oil Emulsion Dressing
DI: 00616784307015
·
Model: 3070
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Oil Emulsion Dressing
- Primary DI
- 00616784307015
- Version / Model
- 3070
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-21
- Public Version
- 4
- Public Version Date
- 2026-03-05
- Public Version Status
- Update
- Public Device Record Key
- 02f3d81d-c63a-4e4e-9c12-4eb8b37d7244
Device Description
Oil Emulsion Dressing, 5"x9", Non-Adherent
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57966 | Pressure-ulcer topical dressing | A solution or emulsion designed to be applied to dermal pressure sores to prevent and treat pressure/decubitus ulcers and lower extremity ulcers. It is composed of natural materials (e.g., ozonized olive oil, sunflower oil, and/or other plant extracts) intended primarily to create a barrier between the skin lesion(s) and the external environment to promote protection and healing. The solution/emulsion is typically dispensed from a spray bottle or other container. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784307022 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00616784307015 | GS1 | ||||
| Package | 00616784307039 | GS1 | Case | 6 | In Commercial Distribution |