Catalog Number

-

Brand Name

Mediflex Universal Round Bar Table Mounted Retractor Systems

Version/Model Number

69589-V

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FFO

Product Code Name

Retractor, Self-Retaining

Public Device Record Key

9215a804-ecc3-4328-8de3-a404f69a568f

Public Version Date

May 25, 2021

Public Version Number

1

DI Record Publish Date

May 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-