Duns Number:440211428
Device Description: Automatic soft tissue biopsy needle 20G x 200MM
Catalog Number
-
Brand Name
MEDONE
Version/Model Number
MO20200-K0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K172344,K172344
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
e4dccadc-ff50-4afe-b185-a42c15df5310
Public Version Date
October 10, 2019
Public Version Number
1
DI Record Publish Date
October 02, 2019
Package DI Number
18052283955699
Quantity per Package
10
Contains DI Package
08052283955692
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 436 |