Duns Number:135057938
Device Description: BARD® MAX-CORE® Disposable Core Biopsy Instrument, 20g x 20cm
Catalog Number
MC2020
Brand Name
BARD® MAX-CORE®
Version/Model Number
MC2020
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
KNW
Product Code Name
INSTRUMENT, BIOPSY
Public Device Record Key
ec2f62b3-a08d-46c2-bcac-1823c96ebd4d
Public Version Date
July 12, 2019
Public Version Number
3
DI Record Publish Date
September 06, 2016
Package DI Number
10801741084529
Quantity per Package
5
Contains DI Package
00801741084522
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |