FDA UDI
In Commercial Distribution
🇺🇸 United States
Dermacea
DI: 20192253049371
·
Model: 442212
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2
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Basic Information
- Brand Name
- Dermacea
- Primary DI
- 20192253049371
- Version / Model
- 442212
- Catalog Number
- 442212
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2024-12-02
- Public Version
- 2
- Public Version Date
- 2025-04-18
- Public Version Status
- Update
- Public Device Record Key
- 8bf01456-ed8e-445b-9e75-d9832f3b5d5c
Device Description
Dermacea USP Type VII Gauze
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
- Yes
- 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 |
|---|---|---|---|---|
| 48134 | Woven gauze pad, non-antimicrobial | A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30192253049378 | GS1 | BOX | 25 | In Commercial Distribution | |
| Primary | 20192253049371 | GS1 | ||||
| Package | 50192253049372 | GS1 | CASE | 24 | In Commercial Distribution | |
| Unit of Use | 10192253049374 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4 | Inch | |
| Width | 4 | Inch |