Identity
- Trade Name
- SynePure Wound Cleanser FDA UDI
- Generic Name
- Non-antimicrobial wound irrigation solution, multiple solute FDA UDI
- Device Name
- SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin. FDA UDI
- Model / Reference
- 8 oz FDA UDI
- Description
- SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852181005301 FDA UDI
- 510(k) Number
- K143444 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 8 Fluid Ounce FDA UDI
Category: Non-antimicrobial wound irrigation solution, multiple solute
SynePure Wound Cleanser by Synedgen, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-antimicrobial wound irrigation solution, multiple solute.
- Levicyn Dermal Spray — Sonoma Pharmaceuticals, Inc. · U
- Lasercyn Dermal Spray — Sonoma Pharmaceuticals, Inc. · U
- CLEAR-LOCK CERAMIC — ORTHO ARCH COMPANY INC · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- Renovar Advanced — H R Pharmaceuticals, Inc. · U
- Hydrocleanse Wound Care Solution — Sonoma Pharmaceuticals, Inc. · U
- PrimaDerm® — Derma Sciences Canada, Inc · U
Cleared under the same submission
K143444 also covers:
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
- Synedgen, Inc.
Sources (1)
- FDA UDI 2100f69e-73cf-48c5-8465-6b22ddb4e745 36 fields · synced Jun 8, 2026