Catalog Number

9244-6001

Brand Name

SPRINT

Version/Model Number

Endura, Sales Configuration

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,K202660,K211801

Product Code

NHI

Product Code Name

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

Public Device Record Key

759e187a-c630-4f63-9535-ef20a7b24371

Public Version Date

January 06, 2022

Public Version Number

4

DI Record Publish Date

September 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-