Duns Number:622768711
Device Description: Polypropylene Glaucoma Drainage Device
Catalog Number
S2
Brand Name
Ahmed™ Glaucoma Valve
Version/Model Number
S2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2019
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K925636
Product Code
KYF
Product Code Name
IMPLANT, EYE VALVE
Public Device Record Key
86ac5462-cff0-45be-a2b7-0d1d4153daac
Public Version Date
October 22, 2019
Public Version Number
4
DI Record Publish Date
March 24, 2015
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |