Catalog Number

C02-4101

Brand Name

Cytoflex Mesh

Version/Model Number

M4-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K021511

Product Code

JEY

Product Code Name

Plate, Bone

Public Device Record Key

75ce23df-4138-479e-b814-e98b6ac9ee5e

Public Version Date

July 27, 2021

Public Version Number

4

DI Record Publish Date

November 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-