Duns Number:308951313
Device Description: Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas, for microscopic examination. When used for breast biopsy, the product is for diagnosis only.
Catalog Number
N30116025
Brand Name
M-Biopsy
Version/Model Number
N30116025
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"
Yes
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
K161409,K161409
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
81dd3ba1-08f0-4782-8bdc-c94354176380
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
05711055002950
Quantity per Package
10
Contains DI Package
15711055002957
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 90 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |