Catalog Number

INS-5031

Brand Name

19 UTW, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point

Version/Model Number

INS-5031

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"

-

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

K093146,K093146

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

2b5ec33e-28f2-460d-863f-88e7d91f9763

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

10815686020320

Quantity per Package

5

Contains DI Package

00815686020323

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-