Duns Number:961027315
Device Description: EYE PACK
Catalog Number
SEY42EPWPG
Brand Name
CARDINAL HEALTH
Version/Model Number
SEY42EPWPG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
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
4a5edac6-180a-4b92-8bc0-0ecc0ed221f6
Public Version Date
February 19, 2021
Public Version Number
1
DI Record Publish Date
February 11, 2021
Package DI Number
50888439993125
Quantity per Package
8
Contains DI Package
10888439993127
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |