Duns Number:961027315
Device Description: LUMBAR LAMINECTOMY PACK
Catalog Number
SNE55LLOKP
Brand Name
CARDINAL HEALTH
Version/Model Number
SNE55LLOKP
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
9c8e2411-1c3f-466c-88d8-014281e0b723
Public Version Date
June 20, 2019
Public Version Number
1
DI Record Publish Date
June 12, 2019
Package DI Number
50888439251829
Quantity per Package
2
Contains DI Package
10888439251821
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 |