Catalog Number

2464AAO

Brand Name

N/A

Version/Model Number

2464AAO

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

HGP

Product Code Name

ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR

Public Device Record Key

afec97c2-5b04-4db7-bb03-08250abb14c3

Public Version Date

October 26, 2020

Public Version Number

4

DI Record Publish Date

October 17, 2016

Package DI Number

20885403252201

Quantity per Package

50

Contains DI Package

10885403252204

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box