Catalog Number

-

Brand Name

MediChoice

Version/Model Number

SWF071

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"

Yes

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

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

6d6675d7-d055-4d2e-afa8-ce82a4fa2c0f

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

September 23, 2020

Package DI Number

50885632127043

Quantity per Package

12

Contains DI Package

10885632127045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-