Catalog Number

1028243

Brand Name

Henry Schein

Version/Model Number

1028243

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)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

DSF

Product Code Name

RECORDER, PAPER CHART

Public Device Record Key

cca541e9-3b5f-4a9a-8578-c12f8c567269

Public Version Date

July 06, 2020

Public Version Number

1

DI Record Publish Date

June 26, 2020

Package DI Number

H65810282432

Quantity per Package

15

Contains DI Package

H65810282431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case