Catalog Number

TX8025-21

Brand Name

DeRoyal

Version/Model Number

TX8025-21

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

ILI

Product Code Name

SLING, ARM

Public Device Record Key

5545e529-e529-409b-ad2f-01c5e5dea43e

Public Version Date

August 18, 2021

Public Version Number

1

DI Record Publish Date

August 10, 2021

Package DI Number

50749756837526

Quantity per Package

24

Contains DI Package

00749756837521

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case