Identity
- Trade Name
- PrimaDerm® FDA UDI
- Generic Name
- Non-antimicrobial wound irrigation solution, multiple solute FDA UDI
- Device Name
- PrimaDerm Wound Cleanser (Preserved). Non-Cytotoxic, No Rinse Formualtion. 4 fl oz bottle. FDA UDI
- Model / Reference
- 69202 FDA UDI
- Description
- PrimaDerm Wound Cleanser (Preserved). Non-Cytotoxic, No Rinse Formualtion. 4 fl oz bottle. FDA UDI
Identifiers
- Catalog Number
- DUP69202 FDA UDI
- Primary DI / UDI-DI
- 10381780491873 FDA UDI
- FDA Product Code
- MGP 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-antimicrobial wound irrigation solution, multiple solute
PrimaDerm® by Derma Sciences Canada, Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Derma Sciences Canada, Inc
Sources (1)
- FDA UDI 4e14adb0-d6d0-4117-9418-88b869c7f07d 37 fields · synced Jun 8, 2026