Catalog Number

-

Brand Name

MINT

Version/Model Number

MINT 12WC1985

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

K130191,K130191

Product Code

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Public Device Record Key

a1956a5c-865e-49f2-b89e-fb9beb1752e1

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

March 23, 2020

Package DI Number

18809556174314

Quantity per Package

5

Contains DI Package

08809556174317

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box Package