Duns Number:135057938
Device Description: VACORA® Vacuum Assisted Biopsy System, Biopsy Probe, 14G x 116mm
Catalog Number
VB14116
Brand Name
VACORA®
Version/Model Number
VB14116
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
8b2d603a-6595-4f41-b78f-3638e2517167
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 2016
Package DI Number
10801741000321
Quantity per Package
5
Contains DI Package
00801741000324
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 |