Catalog Number

496613

Brand Name

1 Piece Introducer w/ Micro Set

Version/Model Number

496613

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

OFL

Product Code Name

Percutaneous Sheath Introducer Kit

Public Device Record Key

3783997d-6030-4eee-8a48-cd94a0135abb

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20886333214185

Quantity per Package

10

Contains DI Package

00886333214181

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box