Catalog Number

-

Brand Name

Typenex Introducer Set

Version/Model Number

MS1835S

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

-

Product Code

OFL

Product Code Name

Percutaneous Sheath Introducer Kit

Public Device Record Key

17b3cd5f-0ffc-4ce6-8c4a-f000944a812b

Public Version Date

February 03, 2021

Public Version Number

1

DI Record Publish Date

January 26, 2021

Package DI Number

00810050853521

Quantity per Package

10

Contains DI Package

00810050853514

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case