Identity
- Trade Name
- Pure&Clean FDA UDI
- Generic Name
- Antimicrobial wound irrigation solution FDA UDI
- Device Name
- Hand Prep 2 oz FDA UDI
- Model / Reference
- 22.06 FDA UDI
- Description
- Hand Prep 2 oz FDA UDI
Identifiers
- Catalog Number
- 3HP2 FDA UDI
- Primary DI / UDI-DI
- 00852421007331 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Antimicrobial wound irrigation solution 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2 Fluid Ounce FDA UDI
Category: Antimicrobial wound irrigation solution
Pure&Clean by Pure & Clean, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antimicrobial wound irrigation solution.
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- ELECTROCYN soma — V3Bio Sdn. Bhd · U
- Shield Products — Digital Ally, Inc. · U
- ExSept Plus — Angelini Pharma Inc. · Class II
- BIAKOS™ Antimicrobial Skin & Wound Cleanser — Sanara Medtech Inc. · U
- Anasept Antimicrobial Skin and Wound Cleanser — Anacapa Technologies, Inc. · Class II
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
- Pure & Clean, LLC
Sources (1)
- FDA UDI 5a4f6378-bc92-41eb-9cfc-afea3e0c4aa6 37 fields · synced May 30, 2026