Catalog Number

-

Brand Name

IRRADIATION INDICATOR TAG

Version/Model Number

RT0201XLB

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

IWZ

Product Code Name

Film, Radiographic

Public Device Record Key

66e3ebaf-6c1c-4c39-8d4f-af0e894f92b5

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

Package DI Number

00810050854887

Quantity per Package

200

Contains DI Package

00810050854870

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case