Duns Number:440211428
Device Description: Semi-automatic disposable biopsy system with adjustable penetration depth 14G X 160 MM
Catalog Number
-
Brand Name
BIO-FEATHER
Version/Model Number
BF14160-C2
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
K142125,K142125
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
7fb20d6c-b631-4cfa-862f-7b81786e790e
Public Version Date
July 12, 2019
Public Version Number
3
DI Record Publish Date
March 07, 2018
Package DI Number
18056515888229
Quantity per Package
10
Contains DI Package
08056515888222
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 |