Catalog Number

5701318

Brand Name

HENRY SCHEIN

Version/Model Number

5701318

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NRU

Product Code Name

CHAIR, DENTAL, WITHOUT OPERATIVE UNIT

Public Device Record Key

6c8a5133-03a0-41b5-8bbd-1456f4b0d022

Public Version Date

February 11, 2019

Public Version Number

1

DI Record Publish Date

January 11, 2019

Package DI Number

20304040103900

Quantity per Package

12

Contains DI Package

10304040103903

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case