Catalog Number

5701321

Brand Name

HENRY SCHEIN

Version/Model Number

5701321

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

ec584886-76f0-444d-a0c1-83e722ccbf77

Public Version Date

February 11, 2019

Public Version Number

1

DI Record Publish Date

January 11, 2019

Package DI Number

20304040103986

Quantity per Package

6

Contains DI Package

10304040103989

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case