Duns Number:008018525
Device Description: CYPASS ULTRA SYSTEM CYPASS MICRO-STENT CYPASS' APPLIER
Catalog Number
-
Brand Name
Cypass
Version/Model Number
8065754007
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"
-
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
bc0746c1-da50-4ddb-acf3-a70779b5531c
Public Version Date
January 24, 2022
Public Version Number
5
DI Record Publish Date
July 19, 2018
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 |