Catalog Number

-

Brand Name

Wavelength

Version/Model Number

NTPE500X

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

K012522,K012522,K012522

Product Code

MUI

Product Code Name

Media, Coupling, Ultrasound

Public Device Record Key

7dfee169-25bb-4e61-a988-aeecaf8051d1

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

November 16, 2016

Package DI Number

20628108100114

Quantity per Package

2

Contains DI Package

00628108100110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box