FDA UDI
In Commercial Distribution
🇺🇸 United States
Tristel OPH
DI: 05060171915744
·
Model: Tristel OPH Foam
·
TRISTEL SOLUTIONS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tristel OPH
- Primary DI
- 05060171915744
- Version / Model
- Tristel OPH Foam
- Company Name
- TRISTEL SOLUTIONS LIMITED
- Labeler DUNS
- 235192791
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-17
- Public Version
- 1
- Public Version Date
- 2025-07-25
- Public Version Status
- New
- Public Device Record Key
- e91a0689-9126-4f45-8530-a18f558e35a0
Device Description
Tristel OPH Foam is ONLY to be used with Tristel OPH Wipes in Tristel OPH. Tristel OPH is a high level disinfectant foam intended to disinfect cleaned, reusable ophthalmic devices.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QWS | Foam Or Gel Chemical Sterilant/High Level Disinfectant | General Hospital | 880.6886 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47631 | Medical device disinfection agent | A non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060171915744 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242732 | 000 |