FDA UDI
In Commercial Distribution
🇺🇸 United States
Tonowash
DI: 00860012823505
·
Model: 1.0
·
Eye-Novation LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tonowash
- Primary DI
- 00860012823505
- Version / Model
- 1.0
- Company Name
- Eye-Novation LLC
- Labeler DUNS
- 079219839
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-15
- Public Version
- 1
- Public Version Date
- 2024-10-23
- Public Version Status
- New
- Public Device Record Key
- 4abd9b3e-cdb0-4c31-a6f6-2c65f9ba583c
Device Description
Device for automatically disinfecting tonometer tips
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MEC | Disinfector, Medical Devices | General Hospital | 880.6992 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66706 | Medical device disinfection solution container | An empty receptacle designed to hold a disinfection solution for subsequent disinfection of a medical device (e.g., dental suction system, water pipeline); it is not intended to hold medical devices or to be used during a medical procedure. It is available in various forms (e.g., open jar, enclosed tank) and may include connection tubing and/or manual controls and valves to regulate the supply of the disinfectant to the medical equipment. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012823505 | GS1 |