Catalog Number

830-059

Brand Name

NeoGen

Version/Model Number

NeoGen 5mm 3x Nozzle (Grey)

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132754,K132754

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

5e1f1b5f-7944-4fe8-9017-bf486d168730

Public Version Date

April 11, 2019

Public Version Number

1

DI Record Publish Date

April 03, 2019

Package DI Number

15060440520256

Quantity per Package

5

Contains DI Package

05060440520259

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton