Duns Number:690635461
Device Description: This delivery unit is connected to the GYC-1000 main body to comprise the photocoagulation This delivery unit is connected to the GYC-1000 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800. A slit lamp delivery unit that includes the SL-1800 comprises a photocoagulation system in connection with the GYC-1000 main body.
Catalog Number
-
Brand Name
Slit lamp delivery unit (SL-1800)
Version/Model Number
17421-0000
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
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
b927189b-7437-4623-8278-f7ac92018402
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 24, 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 |