Catalog Number

-

Brand Name

ACS

Version/Model Number

RWIR61C

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

OIP

Product Code Name

Radiology-diagnostic kit

Public Device Record Key

cd05c9ab-178b-43ff-b21b-ba4da83d0bb5

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

September 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-