Catalog Number

-

Brand Name

MINT

Version/Model Number

MINT-I 95LC1960

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

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Public Device Record Key

cf8082ff-7624-476e-b4cd-bc53888325c4

Public Version Date

May 20, 2022

Public Version Number

1

DI Record Publish Date

May 12, 2022

Package DI Number

18809779586505

Quantity per Package

5

Contains DI Package

08809779586508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box Package