Catalog Number

INS-5903

Brand Name

SPiN Access Catheter Adapter, Pentax

Version/Model Number

INS-5903

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

-

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

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

f7ee3a10-b5e9-476a-855c-8e8d48f3c367

Public Version Date

March 28, 2022

Public Version Number

3

DI Record Publish Date

January 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-