Catalog Number

501

Brand Name

MANI Sutures PGA

Version/Model Number

501

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)

-

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

7b604f72-62c3-4722-9f23-03882ce3731d

Public Version Date

October 18, 2021

Public Version Number

6

DI Record Publish Date

March 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-