Catalog Number

4353

Brand Name

MANI Sutures Polyester

Version/Model Number

4353

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"

-

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

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

9a968758-90ae-4157-9ae3-c406da84beda

Public Version Date

October 18, 2021

Public Version Number

8

DI Record Publish Date

June 04, 2016

Package DI Number

14546951402812

Quantity per Package

12

Contains DI Package

04546951402815

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-