Catalog Number

INS-5611

Brand Name

SPiN Perc Localization Needle 19ga x 105mm, 2cm marking zone

Version/Model Number

INS-5611

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

K170023,K170023

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

c38533ba-06fd-4e01-b1e7-d10a016bc155

Public Version Date

March 28, 2022

Public Version Number

5

DI Record Publish Date

January 25, 2018

Package DI Number

10815686021143

Quantity per Package

5

Contains DI Package

00815686021146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-