Catalog Number

-

Brand Name

NA

Version/Model Number

3352-02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 19, 2017

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

-

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

HTX

Product Code Name

RONGEUR

Public Device Record Key

07d3e02f-5376-4e78-b107-f90dd1b5d128

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-