FDA UDI
In Commercial Distribution
🇺🇸 United States
REFRACTOR
DI: 04987669100820
·
Model: RT-5100
·
NIDEK CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- REFRACTOR
- Primary DI
- 04987669100820
- Version / Model
- RT-5100
- Company Name
- NIDEK CO.,LTD.
- Labeler DUNS
- 690635461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-10
- Public Version
- 3
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- fe729852-a220-49f0-9250-1b632f54d24a
Device Description
The NIDEK REFRACTOR Model RT-5100 is a computerized refractor used for subjective refraction in connection with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/KER/TONOMETER (RKT), or AUTO LENSMETER (LM). The RT-5100 includes a refractor head, control box, relay box, and printer.
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 |
|---|---|---|---|---|
| HKN | Refractor, Manual, Non-Powered, Including Phoropter | Ophthalmic | 886.1770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35299 | Phoropter | An ophthalmic device intended to be placed in front of a patient's eyes to measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an ophthalmic examination, typically to determine a patient's prescription for glasses. It typically consists of two mounted, disk-like housings which contain lenses of different characteristics. It is designed such that the optometrist can change the lenses and other settings while asking the patient to read an eye chart and to provide subjective feedback on which settings give best vision. The setting changes may be manual or automated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987669100820 | GS1 |
Customer Contacts
- Phone
- 1-800-223-9044
- [email protected]