Catalog Number

DN-0800

Brand Name

OptiMicro

Version/Model Number

Needle Electrode, 8cm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K951032,K905263,K905263,K951032,K951032,K905263

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

18cab514-6aaa-4dfa-b1a8-dccc6e864284

Public Version Date

December 18, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

H671DN08002

Quantity per Package

10

Contains DI Package

H671DN08001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Overpack