Duns Number:194550042
Device Description: SPECIMEN KIT, FINE NEEDLE ASPIRATIO
Catalog Number
CA1500
Brand Name
CARDINAL HEALTH
Version/Model Number
CA1500
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAA
Product Code Name
NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
Public Device Record Key
1c74d457-01cc-42fd-a42f-7fe687eaac66
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
April 12, 2019
Package DI Number
50885380122963
Quantity per Package
10
Contains DI Package
10885380122965
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 | 467 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |