NONE - NEUROVISION MEDICAL PRODUCTS, INC.

Duns Number:182057401

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More Product Details

Catalog Number

-

Brand Name

NONE

Version/Model Number

NONE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 23, 2019

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

ETN

Product Code Name

Stimulator, Nerve

Device Record Status

Public Device Record Key

71205e23-18fa-4d06-a03a-dcba37175209

Public Version Date

October 15, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEUROVISION MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 51