Catalog Number

INS-5323

Brand Name

Slidding Stopper 1.4 - 1.9 OD

Version/Model Number

INS-5323

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

K122106,K122106

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

86bb5c58-ac15-4d6f-a25b-2a119a480c07

Public Version Date

November 23, 2021

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

10815686020719

Quantity per Package

10

Contains DI Package

00815686020712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-