Catalog Number

-

Brand Name

X ray Sleeves

Version/Model Number

BCXR

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)

-

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

c7122e77-b48d-4a8c-b496-4c9f2f4a37b0

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Package DI Number

50732224003325

Quantity per Package

12

Contains DI Package

10732224003327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-