Duns Number:961027315
Device Description: KIT, GAMANIZED HEAD FRAME APPL
Catalog Number
SP2JV8302A
Brand Name
CARDINAL HEALTH
Version/Model Number
SP2JV8302A
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)
-
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
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
b055760d-e2fc-4c42-ac7b-bdd055b23b50
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
December 14, 2018
Package DI Number
50888439267394
Quantity per Package
20
Contains DI Package
10888439267396
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 |