Duns Number:690635461
Device Description: The ST-600 is the system table on which the Nidek Refractor RT-6100, RT-3100, or a manuall The ST-600 is the system table on which the Nidek Refractor RT-6100, RT-3100, or a manually operated refractor such as the RT-600 or SLY-100 is installed. The system table allows chart presenting devices (SSC-370, CP-770, SC-1600 series), auto refractometers, lensmeters (LM-1800 series, LM-7 series) to be combined into an ophthalmic workstation. The system table consists of a refractor head lift arm equipped with a refractor head and a motorized main table. While compact, it includes a motorized table with a stroke up to 200 mm for the up-and-down movement, a one-touch swingable refractor head lift arm, and a drawer that can hold 35 types of triallenses.
Catalog Number
-
Brand Name
System Table
Version/Model Number
ST-600
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 29, 2019
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
HRJ
Product Code Name
Table, Instrument, Powered, Ophthalmic
Public Device Record Key
f797b8a7-e58f-4f75-9c4f-7af3f3c88be1
Public Version Date
April 03, 2019
Public Version Number
1
DI Record Publish Date
March 26, 2019
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 |