Duns Number:961027315
Device Description: STRL LUMBAR PUNCTURE, RAD TRAY
Catalog Number
26-9874A
Brand Name
CARDINAL HEALTH
Version/Model Number
26-9874A
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"
-
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
a3de9d6c-fc59-41a7-a40f-0bedb26519a0
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
August 06, 2015
Package DI Number
50887488034438
Quantity per Package
10
Contains DI Package
00887488034433
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 |