Catalog Number

497862

Brand Name

OneStic Micro-Access Introducer

Version/Model Number

497862

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

K780126,K780126,K780126

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

ec70cd0a-4073-4370-8be5-5cd1e296240e

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

June 27, 2017

Package DI Number

10886333223791

Quantity per Package

10

Contains DI Package

00886333223794

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box