Catalog Number

711-1APX-01

Brand Name

Sphenoidal Electrode Set

Version/Model Number

711-1APX-01

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

GZL

Product Code Name

ELECTRODE, DEPTH

Public Device Record Key

e04b44b4-17d7-4b8d-adae-14a770ae1a3b

Public Version Date

October 18, 2018

Public Version Number

1

DI Record Publish Date

September 17, 2018

Package DI Number

90841823100088

Quantity per Package

2

Contains DI Package

00841823100085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-