Identity
- Trade Name
- Polynew FDA UDI
- Generic Name
- Petrolatum woven gauze pad FDA UDI
- Device Name
- Xeroform Petrolatum Dressing 12.5cm×22.5cm FDA UDI
- Model / Reference
- 12.5cm×22.5cm FDA UDI
- Description
- Xeroform Petrolatum Dressing 12.5cm×22.5cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16958868747036 FDA UDI
- 510(k) Number
- K181478 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Petrolatum woven gauze pad FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Petrolatum woven gauze pad
Polynew by Roosin Medical Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Petrolatum woven gauze pad.
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · U
- PETROLATUM GAUZE® — Derma Sciences Canada, Inc · Class II
- Vitale — CellEra, LLC · Class I
- Simpurity — SAFE N SIMPLE LLC · Class I
- Vitale — CellEra, LLC · Class I
- PETROLATUM GAUZE® — Derma Sciences Canada, Inc · Class II
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · U
- Dukal — Dukal LLC · U
Cleared under the same submission
K181478 also covers:
- Durma+ Petrolatum Gauze Dressing, 1" x 8", Neutral Wound, Dressing — Dynarex Corp.
- 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.
- 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
- Roosin Medical Co., Ltd.
Sources (1)
- FDA UDI 0fef5e0c-0b17-4d6f-a56e-cb5fcfe6cd8d 34 fields · synced Jun 7, 2026