Duns Number:961027315
Device Description: KIT,SPINE FUSION ST LOUIS CHIL
Catalog Number
PNVMSUA269
Brand Name
CARDINAL HEALTH
Version/Model Number
PNVMSUA269
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
OJG
Product Code Name
Neurological tray
Public Device Record Key
4eceb48f-f639-4ef6-bca3-7a86568b0a09
Public Version Date
November 29, 2021
Public Version Number
1
DI Record Publish Date
November 19, 2021
Package DI Number
50195594448026
Quantity per Package
1
Contains DI Package
10195594448028
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 |