FDA UDI
In Commercial Distribution
🇺🇸 United States
Dermacea
DI: 50192253048955
·
Model: 441251
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Dermacea
- Primary DI
- 50192253048955
- Version / Model
- 441251
- Catalog Number
- 441251
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-08-02
- Public Version
- 1
- Public Version Date
- 2024-08-12
- Public Version Status
- New
- Public Device Record Key
- 3d1a363d-aa70-450b-ac5b-31895111d894
Device Description
Dermacea Gauze Fluff Roll
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / sponge,nonresorbable for external use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48128 | Gauze strip, non-antimicrobial | A thin length of non-medicated woven material (e.g., cotton, cellulose) primarily designed to pack draining wounds to absorb exudates; it does not include an antimicrobial agent. It may be soaked with medication (not included) before application. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10192253048957 | GS1 | ||||
| Primary | 50192253048955 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 4.5 | Inch | |
| Length | 4.13 | Yard |