Catalog Number

-

Brand Name

NuStat

Version/Model Number

NS-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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160578,K160578,K160578

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

9f34c20e-fa47-42d4-bc98-f069e2b4cc23

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 16, 2022

Package DI Number

00850392006018

Quantity per Package

10

Contains DI Package

00850392006001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Pack