Catalog Number

-

Brand Name

neXus

Version/Model Number

130-35-5502

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190160,K190160

Product Code

LFL

Product Code Name

Instrument, Ultrasonic Surgical

Public Device Record Key

e22ac151-1d5d-48de-953f-82349508d7dd

Public Version Date

July 21, 2020

Public Version Number

1

DI Record Publish Date

July 13, 2020

Package DI Number

00841626103610

Quantity per Package

5

Contains DI Package

00841626103603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box