Catalog Number

-

Brand Name

Sierra NMUS1

Version/Model Number

198289-200

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173265

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

dbbb17ad-6490-4d10-8cc3-328a041d8a11

Public Version Date

February 18, 2022

Public Version Number

1

DI Record Publish Date

February 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-