Catalog Number

C0218

Brand Name

Guideline 4000 5.0™ microTargeting™ Interface Card

Version/Model Number

C0218-00680

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

-

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

K183123

Product Code

GZL

Product Code Name

ELECTRODE, DEPTH

Public Device Record Key

e462eaa3-0f28-4de8-a67d-7a4071321d0b

Public Version Date

February 04, 2019

Public Version Number

1

DI Record Publish Date

January 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-