Catalog Number

S03421-200

Brand Name

Introducer Needle

Version/Model Number

S03421-200

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

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

9abed770-9036-4ec2-bfc0-b0ffcf5ee92b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 18, 2016

Package DI Number

10801741041799

Quantity per Package

25

Contains DI Package

00801741041792

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA