FDA UDI
In Commercial Distribution
🇺🇸 United States
Bordered Gauze
DI: 00714196256669
·
Model: 00256
·
DERMARITE INDUSTRIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Bordered Gauze
- Primary DI
- 00714196256669
- Version / Model
- 00256
- Company Name
- DERMARITE INDUSTRIES LLC
- Labeler DUNS
- 883925562
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-09-01
- Public Version
- 1
- Public Version Date
- 2020-09-09
- Public Version Status
- New
- Public Device Record Key
- 63b2abcf-5521-49ef-bc4c-07ba7480a659
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
- No
- 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 |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63036 | Wound-nonadherent dressing, absorbent, non-sterile | A non-sterile wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel) that prevents adherence to the wound bed, thereby decreasing the potential for wound trauma; it does not contain an antimicrobial agent. It is typically used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00714196256669 | GS1 | ||||
| Unit of Use | 01714196256668 | GS1 |