Catalog Number

-

Brand Name

DOMAS

Version/Model Number

TENS

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121719,K121719

Product Code

GZF

Product Code Name

Stimulator, Peripheral Nerve, Implanted (Pain Relief)

Public Device Record Key

ef49994b-56b9-446c-94b8-58ebb8092c72

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

February 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-