Catalog Number

C-HYB-10D

Brand Name

Zenapro

Version/Model Number

G35476

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2018

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

K111695

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

9d386352-e953-48c4-86e1-76273e95f7f7

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

November 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-