Duns Number:690635461
Device Description: The delivery unit is used for endophotocoagulation. The photocoagulation system can be eas The delivery unit is used for endophotocoagulation. The photocoagulation system can be easily comprised by connecting the optional sterilized endophotoprobe or optional sterilized coaxial illumination probe to the Green Laser Photocoagulator GYC-1000 and GYC-500, and attaching the protective filter to the main laser device as well as the surgical microscope. This photocoagulation system enables laser endophotocoagulation while observing the affected area through the surgical microscope.
Catalog Number
-
Brand Name
Endophotocoagulation Delivery Unit
Version/Model Number
11143-0000(9G4P)
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
62a35754-24a9-4908-8cc7-7db612c36773
Public Version Date
September 16, 2019
Public Version Number
1
DI Record Publish Date
September 07, 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 |