Catalog Number

-

Brand Name

Spex LP

Version/Model Number

SLP35135US

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

K200094,K200094

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

768357ef-66d9-47ce-b1db-486f0bc243fc

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

June 10, 2021

Package DI Number

10850025525029

Quantity per Package

5

Contains DI Package

00850025525022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-