Duns Number:879144426
Device Description: For use during silicone oil procedures, irrigating contact lens enables visualization of s For use during silicone oil procedures, irrigating contact lens enables visualization of surgical field while ensuring proper irrigation of cornea and orbit. Single -use requiring no clean up.
Catalog Number
TR9840-11
Brand Name
Irrigating Contact Lens
Version/Model Number
Flat
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
Yes
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
K924999
Product Code
KYG
Product Code Name
Device, Irrigation, Ocular Surgery
Public Device Record Key
8baf9317-8a69-44a5-9a9e-b93601129528
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 14, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |