Catalog Number

-

Brand Name

MINNE TIES

Version/Model Number

IN-6032-R

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"

Yes

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

K162046

Product Code

DYX

Product Code Name

Lock, Wire, And Ligature, Intraoral

Public Device Record Key

180b1539-8a4e-44a6-b943-8d144b499001

Public Version Date

August 23, 2021

Public Version Number

2

DI Record Publish Date

February 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-