Catalog Number

9916100

Brand Name

4Med

Version/Model Number

9916100

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

FZW

Product Code Name

Expander, Surgical, Skin Graft

Public Device Record Key

a3380b94-6069-47f0-badc-d9ffe3d3f4a9

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-