Identity
- Trade Name
- Dakin's Wound Cleanser 16oz w/ cap FDA UDI
- Generic Name
- Non-antimicrobial wound irrigation solution, multiple solute FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00304365201615 FDA UDI
- 510(k) Number
- K090791 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Non-antimicrobial wound irrigation solution, multiple solute FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Non-antimicrobial wound irrigation solution, multiple solute
Dakin's Wound Cleanser 16oz w/ cap by Century Pharmaceuticals, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-antimicrobial wound irrigation solution, multiple solute.
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Cleared under the same submission
K090791 also covers:
- Dakin's Wound Cleanser 16oz w/ Septum Cap — CENTURY PHARMACEUTICALS, INC.
- Dakin's Wound Cleanser 8 oz w/ cap — CENTURY PHARMACEUTICALS, INC.
- Dakin's Wound Cleanser 8oz w/ sprayer — CENTURY PHARMACEUTICALS, INC.
- Dakin's Wound Cleanser Pro 16oz w/ Septum Cap — CENTURY PHARMACEUTICALS, INC.
- Dakin's Wound Cleanser Pro 8oz w/ Cap — CENTURY PHARMACEUTICALS, INC.
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
- Century Pharmaceuticals, Inc.
Sources (1)
- FDA UDI 4f128bd0-ffa5-4dba-aa34-da4156f62764 34 fields · synced Jun 8, 2026