Duns Number:690635461
Device Description: This dual delivery unit is used in connection with the green laser photocoagulator GYC-100 This dual delivery unit is used in connection with the green laser photocoagulator GYC-1000. Using this unit enables connection of two types of delivery units to a unit of GYC-1000. The desired connected delivery unit can be selected and used with easy switching.
Catalog Number
-
Brand Name
Dual delivery unit
Version/Model Number
17174-0000
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
4d9c59c5-f641-48c2-8393-012678a5ed52
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 03, 2017
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 |