Identity
- Trade Name
- Tristel ULT FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Tristel ULT Foam is ONLY to be used with Tristel ULT Wipes in Tristel ULT. Tristel ULT is a high level disinfectant foam intended to disinfect cleaned, reusable, non-lumened ultrasound probes. FDA UDI
- Model / Reference
- Tristel ULT Foam FDA UDI
- Description
- Tristel ULT Foam is ONLY to be used with Tristel ULT Wipes in Tristel ULT. Tristel ULT is a high level disinfectant foam intended to disinfect cleaned, reusable, non-lumened ultrasound probes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060171914549 FDA UDI
- 510(k) Number
- DEN220041 FDA UDI
- FDA Product Code
- QWS FDA UDI
- GMDN Term
- Medical device disinfection agent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6886 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device disinfection agent
Tristel ULT by Tristel Solutions Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Tristel Solutions Limited
Sources (1)
- FDA UDI cc2b43cd-0b04-478e-a4e2-0ec82a3419e9 34 fields · synced May 30, 2026