Catalog Number

BB-0528X-1

Brand Name

BARRIER

Version/Model Number

BB-0528X

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

K922175,K922175,K922175

Product Code

KLC

Product Code Name

Chair, Dental, With Operative Unit

Public Device Record Key

a12db8a1-d5e4-4832-a7d1-7bedd5473fb7

Public Version Date

November 01, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

H816BB0528X2

Quantity per Package

10

Contains DI Package

H816BB0528X1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Box