Catalog Number

-

Brand Name

Globus Medical

Version/Model Number

675.701S

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GXZ

Product Code Name

Electrode, Needle

Public Device Record Key

2f2f6ce0-4f3d-466a-bf4f-f3a681fde480

Public Version Date

September 20, 2021

Public Version Number

3

DI Record Publish Date

June 27, 2017

Package DI Number

08718375865323

Quantity per Package

1

Contains DI Package

08718375865279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pouch