Catalog Number

-

Brand Name

Aculife

Version/Model Number

IDOC-01 Vitall

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BWK

Product Code Name

Stimulator, Electro-Acupuncture

Public Device Record Key

0299f320-43d3-40e3-b303-a1f927c59171

Public Version Date

December 28, 2018

Public Version Number

1

DI Record Publish Date

November 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-