Duns Number:106580145
Device Description: Basic Eye Minor Kit
Catalog Number
E532BCB
Brand Name
Aligned Medical Solutions
Version/Model Number
E532BCB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OJK
Product Code Name
Eye tray
Public Device Record Key
b84a7e7c-7c3c-4943-8b66-ec57bbc661ac
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
November 14, 2018
Package DI Number
B098E532BCB1
Quantity per Package
10
Contains DI Package
B098E532BCB0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 578 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1711 |