Catalog Number

4005B

Brand Name

Mediflex

Version/Model Number

4005B

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

-

Product Code

GAD

Product Code Name

Retractor

Public Device Record Key

e9283ee1-b24d-4a69-9b44-1160587df175

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

December 18, 2020

Package DI Number

08904332600223

Quantity per Package

5

Contains DI Package

08904332600216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box