Catalog Number

-

Brand Name

MR Stylet

Version/Model Number

4013-06

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

GAH

Product Code Name

Stylet, Surgical, General & Plastic Surgery

Public Device Record Key

3372b3fe-977e-4dde-950e-f67365850eeb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 06, 2016

Package DI Number

57340007000480

Quantity per Package

10

Contains DI Package

17340007000482

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-