Duns Number:428898555
Device Description: TOP CUT 16GX150MM
Catalog Number
TOP 1615
Brand Name
TOP CUT
Version/Model Number
TOP CUT
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
K021525,K021525
Product Code
FCG
Product Code Name
Biopsy Needle
Public Device Record Key
64e39165-b76e-4a76-b951-f47ecbf538a6
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
December 04, 2016
Package DI Number
38033003347486
Quantity per Package
10
Contains DI Package
08033003347485
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 79 |