Catalog Number

9874-001-16122

Brand Name

RO 1750 ROT 350

Version/Model Number

9874-001-16122

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

-

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

ITY

Product Code Name

Assembly, tube housing, x-ray, diagnostic

Public Device Record Key

4d224bf1-1eec-4f15-a834-7c99cb41fae2

Public Version Date

February 11, 2019

Public Version Number

1

DI Record Publish Date

January 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-