Catalog Number

-

Brand Name

Wavelength

Version/Model Number

NTPD351X

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

K013212,K013212

Product Code

MUI

Product Code Name

Media,Coupling,Ultrasound

Public Device Record Key

2bc33da3-b8ab-47c0-944e-f43a2f441829

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

November 16, 2016

Package DI Number

10628108100162

Quantity per Package

4

Contains DI Package

00628108100165

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box