Duns Number:429113525
Device Description: Biopsy Digit device uses two stereo images taken by a digital solid state camera to determ Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
Catalog Number
9100-01
Brand Name
BIOPSY DIGIT
Version/Model Number
BIOPSY DIGIT AM
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
-
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
K990192,K990192
Product Code
IZH
Product Code Name
System, X-Ray, Mammographic
Public Device Record Key
6dd542fb-d069-42ff-9a28-323e1eedea65
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
18033837190216
Quantity per Package
1
Contains DI Package
08033837190219
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
N006643
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |