Catalog Number

001-033950

Brand Name

Masterline

Version/Model Number

001-033950

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 27, 2022

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

-

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

ECP

Product Code Name

INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC

Public Device Record Key

75722992-6879-4b12-943f-9a7eb4c8ed91

Public Version Date

May 27, 2022

Public Version Number

2

DI Record Publish Date

August 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-