Catalog Number

-

Brand Name

Disc-FX® Guidewire

Version/Model Number

DFX-GW-S/1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

717e9000-bb9a-4078-b426-cf69ce0af58f

Public Version Date

October 05, 2018

Public Version Number

2

DI Record Publish Date

July 26, 2018

Package DI Number

00846338001322

Quantity per Package

10

Contains DI Package

00846338010911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box (DFX-GW-S)