Catalog Number

EXIS

Brand Name

ThruPort Systems Embol-X Introducer Sheath

Version/Model Number

EXIS

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

K123714

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

b975cff6-9f98-44d0-92f5-3d8b5960ff03

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-