Catalog Number

4035413

Brand Name

Safety Excalibur Introducer System with Punctur-Guard

Version/Model Number

4035413

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

-

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

36bc531d-00a6-492e-99f0-9d027bc0c866

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 06, 2017

Package DI Number

10801741074810

Quantity per Package

5

Contains DI Package

00801741074813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA