Catalog Number

4005S-2

Brand Name

Mediflex

Version/Model Number

4005S-2

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

d05317fb-d592-4678-b8b0-a58be0b6e79c

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

November 13, 2020

Package DI Number

08904332600308

Quantity per Package

5

Contains DI Package

08904332600292

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box