Duns Number:690635461
Device Description: The NIDEK REFRACTOR Model RT-5100 is a computerized refractor used for subjective refracti 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.
Catalog Number
-
Brand Name
REFRACTOR
Version/Model Number
RT-5100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HKN
Product Code Name
Refractor, Manual, Non-Powered, Including Phoropter
Public Device Record Key
fe729852-a220-49f0-9250-1b632f54d24a
Public Version Date
December 21, 2020
Public Version Number
3
DI Record Publish Date
August 10, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |
| 3 | A medical device with high risk that requires premarket approval | 5 |