Catalog Number

-

Brand Name

Wavelength

Version/Model Number

NTPC025X

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

Yes

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

c941e0d5-deb8-4e3e-b26a-a767f504296e

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

June 04, 2019

Package DI Number

20628108100275

Quantity per Package

400

Contains DI Package

00628108100271

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case