Catalog Number

234-500-214

Brand Name

NA

Version/Model Number

234-500-214

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 07, 2018

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

HTO

Product Code Name

REAMER

Public Device Record Key

6813f9d3-f5c0-4d85-9caf-c7d8f9d8f0e5

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

September 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-