Catalog Number

32-087

Brand Name

DeRoyal

Version/Model Number

32-087

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

12744563-1e0d-49f2-a39a-4f9ebc4865c9

Public Version Date

August 13, 2021

Public Version Number

1

DI Record Publish Date

August 05, 2021

Package DI Number

50749756035113

Quantity per Package

100

Contains DI Package

00749756035118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case