Catalog Number

INS-5028

Brand Name

19 UTW, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point

Version/Model Number

INS-5028

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

d75dab2c-3e95-49a6-bb5d-6e86926580cf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

10815686020290

Quantity per Package

5

Contains DI Package

00815686020293

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-