Duns Number:140727624
Device Description: SuperCore™ Biopsy Instrument 14ga x 9cm (use with optional Co-Axial Needle MCXS1409LX)
Catalog Number
701114090M
Brand Name
SuperCore™ Biopsy Instrument
Version/Model Number
701114090M
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
bdc60143-519d-4b3f-b461-b5d4ad14dbfb
Public Version Date
June 24, 2021
Public Version Number
1
DI Record Publish Date
June 16, 2021
Package DI Number
20886333225631
Quantity per Package
10
Contains DI Package
00886333225637
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |