Catalog Number

-

Brand Name

NuStat Trauma Pad XR

Version/Model Number

XR-0404

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

K183190,K183190

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

098a85e5-5aea-44ba-97df-3e7096e1f4a1

Public Version Date

September 19, 2022

Public Version Number

2

DI Record Publish Date

January 08, 2021

Package DI Number

10850392006596

Quantity per Package

50

Contains DI Package

00850392006599

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Pack