Catalog Number

PFM0412

Brand Name

ACell®

Version/Model Number

PFM0412

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 05, 2018

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

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

FTM

Product Code Name

Mesh, surgical

Public Device Record Key

7509c316-827c-48fe-8b7a-32be132db253

Public Version Date

January 26, 2022

Public Version Number

7

DI Record Publish Date

January 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-