FDA UDI
In Commercial Distribution
🇺🇸 United States
Ocu-Film® +"
DI: 00812559012485
·
Model: 230653
·
REICHERT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ocu-Film® +"
- Primary DI
- 00812559012485
- Version / Model
- 230653
- Company Name
- REICHERT, INC.
- Labeler DUNS
- 126650253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-15
- Public Version
- 1
- Public Version Date
- 2025-08-25
- Public Version Status
- New
- Public Device Record Key
- f513fe50-400a-4119-bc06-fcb64166a8cf
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HKY | Tonometer, Manual | Ophthalmic | 886.1930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45750 | Ophthalmic tonometer tip cover | A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. It is made of natural rubber latex or synthetic polymer materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812559012485 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070534 | 000 |