Catalog Number

1064787

Brand Name

Henry Schein

Version/Model Number

1064787

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

ECM

Product Code Name

BAND, PREFORMED, ORTHODONTIC

Public Device Record Key

161692bc-2990-4657-a0a6-7daa3dad93f9

Public Version Date

February 13, 2020

Public Version Number

1

DI Record Publish Date

February 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-