Catalog Number

-

Brand Name

Relivion

Version/Model Number

PAD0001A

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

K212106,K212106

Product Code

PCC

Product Code Name

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Public Device Record Key

53ad4f65-9128-431b-b4cc-712f7ceecc4e

Public Version Date

December 13, 2021

Public Version Number

1

DI Record Publish Date

December 05, 2021

Package DI Number

17290018393014

Quantity per Package

10

Contains DI Package

07290018393017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box