Catalog Number

5702626

Brand Name

Henry Schein

Version/Model Number

5702626

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

KXR

Product Code Name

APPLICATOR, RESIN

Public Device Record Key

f690dfe2-b4fd-45bb-a376-5a9f057dc3a6

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 07, 2021

Package DI Number

20304040055988

Quantity per Package

25

Contains DI Package

10304040055981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case