Catalog Number

00-2195-014-00

Brand Name

MeshgraftTM II Tissue Expansion System

Version/Model Number

00-2195-014-00

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)

Yes

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

0a59ecea-56a9-4adb-aa7c-bd901614d012

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Package DI Number

00889024378797

Quantity per Package

20

Contains DI Package

00889024372573

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box