Catalog Number

1068730

Brand Name

Henry Schein

Version/Model Number

1068730

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

ECN

Product Code Name

CLAMP, WIRE, ORTHODONTIC

Public Device Record Key

29fd7030-6be2-451a-b8b3-7be506ef311d

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-