Duns Number:008018525
Device Description: CyPass System
Catalog Number
-
Brand Name
CyPass
Version/Model Number
8065754003
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 2018
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"
Yes
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
OGO
Product Code Name
Intraocular Pressure Lowering Implant
Public Device Record Key
b0936350-2dad-436f-adcc-84ef06d2fc78
Public Version Date
August 24, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
10380657540034
Quantity per Package
5
Contains DI Package
00380657540037
Package Discontinue Date
August 28, 2018
Package Status
Not in Commercial Distribution
Package Type
BOX
| 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 |