Catalog Number

9244-6001B

Brand Name

SPRINT

Version/Model Number

9244-6001B

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

K202660,K211801

Product Code

NHI

Product Code Name

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

Public Device Record Key

c5f5261b-6491-49c0-b8e4-48818f6da82c

Public Version Date

November 02, 2021

Public Version Number

1

DI Record Publish Date

October 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-