FDA UDI
In Commercial Distribution
🇺🇸 United States
Durma+ Small Foam Dressing, 4" x 2"
DI: 00840117342231
·
Model: 3126
·
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+ Small Foam Dressing, 4" x 2"
- Primary DI
- 00840117342231
- Version / Model
- 3126
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-02
- Public Version
- 1
- Public Version Date
- 2025-06-10
- Public Version Status
- New
- Public Device Record Key
- 9458f51b-af31-47d4-8928-ec0f47ed2771
Device Description
Sterile-R
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 |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47407 | Negative-pressure wound therapy system foam dressing, antimicrobial | A pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT), and that contains an antimicrobial agent [e.g., silver (Ag)]. It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840117342231 | GS1 | ||||
| Package | 00840117342200 | GS1 | Case | 10 | In Commercial Distribution |