Catalog Number

-

Brand Name

SPEX35

Version/Model Number

SPN35090US

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

K173662,K173662

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

aabf4b4d-822c-4e40-99dc-51f04ef58645

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

September 23, 2021

Package DI Number

10850025525074

Quantity per Package

5

Contains DI Package

00850025525077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-