Identity
- Trade Name
- PrimaDerm® FDA UDI
- Generic Name
- Non-antimicrobial wound irrigation solution, multiple solute, sterile FDA UDI
- Device Name
- PrimaDerm Dermal Cleanser (Preservative Free) 4 fl oz Bottle. Sterile FDA UDI
- Model / Reference
- 69101 FDA UDI
- Description
- PrimaDerm Dermal Cleanser (Preservative Free) 4 fl oz Bottle. Sterile FDA UDI
Identifiers
- Catalog Number
- DUP69101 FDA UDI
- Primary DI / UDI-DI
- 10381780491859 FDA UDI
- FDA Product Code
- MGP FDA UDI
- GMDN Term
- Non-antimicrobial wound irrigation solution, multiple solute, sterile 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
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, sterile
PrimaDerm® by Derma Sciences Canada, 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, sterile.
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 84aa12e3-4ee6-40fa-ab5c-facb8c3250e9 37 fields · synced Jun 8, 2026