Catalog Number

-

Brand Name

A.J. WILCOCK® TRUEFORM™ AUSTRALIAN WIRE SOLO-PACK™

Version/Model Number

AWTFL018SP+S

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

DZC

Product Code Name

Wire, Orthodontic

Public Device Record Key

f00a040e-dc8b-4faa-84ed-0ac38abc4582

Public Version Date

July 09, 2020

Public Version Number

1

DI Record Publish Date

July 01, 2020

Package DI Number

20190886010782

Quantity per Package

10

Contains DI Package

10190886010785

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-