Duns Number:961027315
Device Description: SPINAL TRAY
Catalog Number
13-0266K
Brand Name
CARDINAL HEALTH
Version/Model Number
13-0266K
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
OFU
Product Code Name
Spinal anesthesia kit
Public Device Record Key
d995e6d2-076e-4edf-810f-c1a34ab903fb
Public Version Date
September 06, 2018
Public Version Number
1
DI Record Publish Date
August 06, 2018
Package DI Number
50888439073599
Quantity per Package
25
Contains DI Package
10888439073591
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 |