Duns Number:961027315
Device Description: BREAST BIOSPSY TRAY
Catalog Number
22A0070B
Brand Name
CARDINAL HEALTH
Version/Model Number
22A0070B
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)
Yes
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
MJG
Product Code Name
DEVICE, PERCUTANEOUS, BIOPSY
Public Device Record Key
1910a753-b18e-4b45-98ab-334b80f5c51e
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
April 24, 2019
Package DI Number
50888439411551
Quantity per Package
20
Contains DI Package
10888439411553
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 |