Duns Number:008018525
Device Description: EX-PRESS® Glaucoma Filtration Device - Version P-200
Catalog Number
-
Brand Name
EX-PRESS®
Version/Model Number
P-200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 25, 2018
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
-
Product Code
KYF
Product Code Name
Implant, Eye Valve
Public Device Record Key
7239a1de-6042-4a14-bd5e-aa69763840c7
Public Version Date
August 24, 2021
Public Version Number
4
DI Record Publish Date
October 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 | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |