Duns Number:440211428
Device Description: Soft Tissue Programmable Automatic Biopsy System 12G X 100 mm
Catalog Number
-
Brand Name
MEDONE ULTRA
Version/Model Number
MU12100-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
K192101,K192101
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
d90bd708-f311-4531-969a-32a005aea690
Public Version Date
May 13, 2020
Public Version Number
1
DI Record Publish Date
May 05, 2020
Package DI Number
18052286423294
Quantity per Package
5
Contains DI Package
08052286423297
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 |