Catalog Number

-

Brand Name

neXus

Version/Model Number

100-21-0003

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190160

Product Code

LFL

Product Code Name

Instrument, Ultrasonic Surgical

Public Device Record Key

bf58b7f8-1cc7-41c0-80f3-10ebbda4fe11

Public Version Date

March 03, 2020

Public Version Number

1

DI Record Publish Date

February 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-