Catalog Number

-

Brand Name

McKesson

Version/Model Number

115-2G

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ITG

Product Code Name

Bandage, Cast

Public Device Record Key

0683bc0d-a8c6-4974-83f5-4f37d7ee0b41

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Package DI Number

20612479180387

Quantity per Package

10

Contains DI Package

10612479194530

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box