Duns Number:961027315
Device Description: US IMAGE GUIDED BIOPSY
Catalog Number
32-3502A
Brand Name
CARDINAL HEALTH
Version/Model Number
32-3502A
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
OIJ
Product Code Name
Biopsy needle guide kit
Public Device Record Key
9907890f-fc4a-4fbb-8e89-f4e1501c8613
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
July 08, 2016
Package DI Number
50887488167495
Quantity per Package
20
Contains DI Package
10887488167497
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 |