Catalog Number

INS-5411

Brand Name

0.016" Stylet, 1235mm L

Version/Model Number

INS-5411

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"

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

K170023,K170023

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

25f2e7c3-df8c-4722-a5c0-a25a5c5b7369

Public Version Date

March 28, 2022

Public Version Number

3

DI Record Publish Date

January 30, 2020

Package DI Number

10815686021198

Quantity per Package

5

Contains DI Package

00815686021191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-