StimQ Receiver Stimulator Kit Channel A US w/Receiver - StimQ Peripheral Nerve Stimulator System StimQ - STIMWAVE TECHNOLOGIES INCORPORATED

Duns Number:078294927

Device Description: StimQ Peripheral Nerve Stimulator System StimQ Receiver Stimulator Kit Channel A US w/Rece

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More Product Details

Catalog Number

-

Brand Name

StimQ Receiver Stimulator Kit Channel A US w/Receiver

Version/Model Number

STQ4-RCV-A0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171366

Product Code Details

Product Code

GZF

Product Code Name

Stimulator, Peripheral Nerve, Implanted (Pain Relief)

Device Record Status

Public Device Record Key

699d4362-ed5b-46ff-85a0-8831bf3e59d3

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

February 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STIMWAVE TECHNOLOGIES INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 58