Duns Number:012835406
Device Description: Trabecular Micro-Bypass System
Catalog Number
iS3
Brand Name
iStent infinite
Version/Model Number
iS3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 19, 2022
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K220032
Product Code
KYF
Product Code Name
Implant, Eye Valve
Public Device Record Key
09fc26ad-d4c3-46cb-a195-44e8471c72ca
Public Version Date
October 20, 2022
Public Version Number
2
DI Record Publish Date
October 05, 2022
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |
| 3 | A medical device with high risk that requires premarket approval | 5 |