Catalog Number

1047974

Brand Name

Henry Schein

Version/Model Number

1047974

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EKM

Product Code Name

GUTTA-PERCHA

Public Device Record Key

d1d63cb6-1e87-4147-9b4e-dabeff6b0db5

Public Version Date

July 06, 2020

Public Version Number

1

DI Record Publish Date

June 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-