Catalog Number

854-034072

Brand Name

Plastic Tie

Version/Model Number

854-034072

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

-

Product Code

ECI

Product Code Name

BAND, ELASTIC, ORTHODONTIC

Public Device Record Key

ec0e470b-ff24-4d32-8776-da838087afbc

Public Version Date

May 05, 2022

Public Version Number

3

DI Record Publish Date

June 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-