Catalog Number

P152830

Brand Name

Permacol

Version/Model Number

P152830

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 22, 2015

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

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

K992556

Product Code

FTM

Product Code Name

Mesh, surgical

Public Device Record Key

fc99c46c-a56f-4d19-9202-4115176891c7

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

October 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-