Catalog Number

-

Brand Name

Spes Medica Subdermal Needle Electrodes

Version/Model Number

TT03MN4013D/25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

K192603,K192603

Product Code

GXZ

Product Code Name

Electrode, Needle

Public Device Record Key

87c0e508-b7fd-4a1a-8a8e-f7c9044cfdee

Public Version Date

February 05, 2020

Public Version Number

1

DI Record Publish Date

January 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-