FDA UDI
In Commercial Distribution
🇺🇸 United States
Durma+ Unna Boot Bandage with Zinc Oxide
DI: 00616784345413
·
Model: 3454
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Durma+ Unna Boot Bandage with Zinc Oxide
- Primary DI
- 00616784345413
- Version / Model
- 3454
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-17
- Public Version
- 1
- Public Version Date
- 2025-12-25
- Public Version Status
- New
- Public Device Record Key
- 5706f4fe-fdca-4293-ac7d-18ae6efbbc26
Device Description
4" x 10 yd (10.2 cm x 9.1m)
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEC | Bandage, Liquid, Skin Protectant | General Hospital | 880.5090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62535 | Skin-cover sealant | A biodegradable, synthetic (e.g., cyanoacrylate) substance intended to be applied over a superficial wound to set and form a barrier to reduce skin exposure to external contaminants. Sometimes referred to as a liquid bandage, it is intended for use in the home or a clinical setting and may be intended as an alternative to a conventional skin-cover adhesive strip. 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 | 00616784345437 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00616784345413 | GS1 |