Catalog Number

3375

Brand Name

MANI Sutures Polyester

Version/Model Number

3375

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

99ad6a36-e938-4814-89e9-cac448e08e0e

Public Version Date

October 18, 2021

Public Version Number

8

DI Record Publish Date

June 04, 2016

Package DI Number

14546951400757

Quantity per Package

12

Contains DI Package

04546951400750

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-