Identity
- Trade Name
- Tristel OPH FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Tristel OPH is a high level disinfectant foam intended to disinfect cleaned, reusable ophthalmic devices. Supplied as a dual compartment Tristel OPH Foam bottle, a tub of Tristel OPH Wipes and a User Guide. FDA UDI
- Model / Reference
- TSL025126 (case of 2 boxes) FDA UDI
- Description
- Tristel OPH is a high level disinfectant foam intended to disinfect cleaned, reusable ophthalmic devices. Supplied as a dual compartment Tristel OPH Foam bottle, a tub of Tristel OPH Wipes and a User Guide. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060171915720 FDA UDI
- 510(k) Number
- K242732 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
- Not 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
Tristel OPH by Tristel Solutions Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K242732 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 II | Pending data |
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Manufacturer
- Manufacturer
- Tristel Solutions Limited
Sources (1)
- FDA UDI ab5d524a-08fc-46a7-a850-d96710aff479 35 fields · synced Jun 8, 2026