Catalog Number

-

Brand Name

DYNA-FLEX™

Version/Model Number

7025

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

MCY

Product Code Name

Wound Dressing Kit

Public Device Record Key

12a68470-31a7-497a-828e-eb18194eb034

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2018

Package DI Number

55051978003425

Quantity per Package

8

Contains DI Package

15051978003427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-