Duns Number:429113525
Device Description: Biopsy Digit SL is a medical device intended to be used for mamnmographic procedures requi Biopsy Digit SL is a medical device intended to be used for mamnmographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
Catalog Number
9201-01
Brand Name
BIOPSY DIGIT
Version/Model Number
BIOPSY DIGIT SL
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
K113607,K113607
Product Code
IZH
Product Code Name
System, X-Ray, Mammographic
Public Device Record Key
e9635ffd-715d-42e1-9c68-76681ef43fb2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
18033837190209
Quantity per Package
1
Contains DI Package
08033837190202
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 |