FDA UDI
In Commercial Distribution
🇺🇸 United States
VISUPLAN 500
DI: 00812559012195
·
Model: 16080
·
REICHERT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VISUPLAN 500
- Primary DI
- 00812559012195
- Version / Model
- 16080
- Company Name
- REICHERT, INC.
- Labeler DUNS
- 126650253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2020-11-09
- Public Version Status
- Update
- Public Device Record Key
- 5f957036-35ea-4da3-9a6c-c26fa455e555
Device Description
AC-powered, non-contact tonometer indicated for measuring intraocular pressure (IOP) to aid in the screening and diagnosis of glaucoma. An air puff is used to momentarily flatten a patient's cornea during the measurement.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HKX | Tonometer, Ac-Powered | Ophthalmic | 886.1930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35399 | Ophthalmic tonometer, line-powered | An ophthalmic, line-powered, measuring instrument used for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). It typically has no contact with the eye and can use various techniques, e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air; the applanation tonometer records the indentation pressure in thousands of a second. It is used for the diagnosis of glaucoma, designed for table top use and may provide the data on a screen and/or a print-out. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812559012195 | GS1 |
Customer Contacts
- Phone
- 1-888-849-8955
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990869 | 000 |