Catalog Number

-

Brand Name

NuStat Flex XR

Version/Model Number

XR-3000097317

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

K160578

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

446c0540-2ef1-498e-8f30-37a2c62556c4

Public Version Date

January 18, 2021

Public Version Number

1

DI Record Publish Date

January 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-