Duns Number:174262477
Device Description: CUSTOM CONVENIENCE KIT FOR EYE BANK (CORNEA TRAY)
Catalog Number
689-300
Brand Name
STRADIS
Version/Model Number
689-300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 23, 2022
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
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
PZG
Product Code Name
Surgical Eye Tray
Public Device Record Key
925f3b9e-ce37-48e6-9e55-b0cb3fa7d9c7
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
May 04, 2016
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 | 1226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1431 |
| U | Unclassified | 10 |