Catalog Number

80086

Brand Name

SPRINT

Version/Model Number

80086

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"

Yes

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

K181422

Product Code

NHI

Product Code Name

Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

Public Device Record Key

459a30a2-66d3-4cfd-ac85-ae2acb0c6d3f

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

March 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-