Catalog Number

RD14R-SP03X-000

Brand Name

Depth Electrode

Version/Model Number

RD14R-SP03X-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

September 01, 2106

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

e0704f2a-49c9-4436-89c3-8623862afe13

Public Version Date

September 23, 2019

Public Version Number

2

DI Record Publish Date

September 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-