NSS IB-STIM - The IB-STIM (DEN180057) is a percutaneous - Neuraxis, Inc.

Duns Number:063076701

Device Description: The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system

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More Product Details

Catalog Number

01-1020

Brand Name

NSS IB-STIM

Version/Model Number

IB-STIM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

QHH

Product Code Name

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Device Record Status

Public Device Record Key

7a772919-6c75-4ab6-86ea-7097ba69c0a5

Public Version Date

October 21, 2022

Public Version Number

4

DI Record Publish Date

November 09, 2020

Additional Identifiers

Package DI Number

B960NSS2031

Quantity per Package

10

Contains DI Package

B960NSS203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box