Catalog Number

Sertera Intro-12

Brand Name

Sertera Introducer

Version/Model Number

Sertera Intro-12

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GDF

Product Code Name

GUIDE, NEEDLE, SURGICAL

Public Device Record Key

f95d7237-6209-41c8-bbf9-dc5d7b5ddc6a

Public Version Date

October 10, 2022

Public Version Number

3

DI Record Publish Date

April 13, 2017

Package DI Number

25420045504179

Quantity per Package

5

Contains DI Package

15420045504172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX