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Durma+ Petrolatum Gauze Dressing, 1" x 8", Neutral Wound, Dressing
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- Durma+ Petrolatum Gauze Dressing, 1" x 8", Neutral Wound, Dressing FDA UDI
- Generic Name
- Wound-nonadherent dressing, permeable, non-antimicrobial FDA UDI
- Device Name
- 3% Bismuth Tribromophenate in a Petrolatum Blend, Sterile-R FDA UDI
- Model / Reference
- 3044 FDA UDI
- Description
- 3% Bismuth Tribromophenate in a Petrolatum Blend, Sterile-R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117345829 FDA UDI
- 510(k) Number
- K181478 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound-nonadherent dressing, permeable, non-antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wound-nonadherent dressing, permeable, non-antimicrobial
Durma+ Petrolatum Gauze Dressing, 1" x 8", Neutral Wound, Dressing by Dynarex Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181478 also covers:
- Dr.Med — Roosin Medical Co., Ltd.
- Dr.Med — Roosin Medical Co., Ltd.
- Dr.Med — Roosin Medical Co., Ltd.
- Dr.Med — Roosin Medical Co., Ltd.
- Polynew — Roosin Medical Co., Ltd.
- Polynew — Roosin Medical Co., Ltd.
- Polynew — Roosin Medical Co., Ltd.
- Polynew — Roosin Medical Co., Ltd.
- ViveCare — VIVE HEALTH LLC
- ViveCare — VIVE HEALTH LLC
- ViveCare — VIVE HEALTH LLC
- ViveCare — VIVE HEALTH LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 2d4e5154-0a59-4069-897d-b4f05b08eef3 34 fields · synced May 30, 2026