Catalog Number

3392

Brand Name

MANI Sutures PGA

Version/Model Number

3392

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

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

b7e7efd6-8a0f-4698-b9e2-5b9df341996d

Public Version Date

October 18, 2021

Public Version Number

6

DI Record Publish Date

June 15, 2016

Package DI Number

14546951403833

Quantity per Package

12

Contains DI Package

04546951403836

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-