VERIDIAN - TENS unit with remote - VERIDIAN HEALTHCARE LLC

Duns Number:830437997

Device Description: TENS unit with remote

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More Product Details

Catalog Number

-

Brand Name

VERIDIAN

Version/Model Number

22-041

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

For Single-Use

-

Prescription Use (Rx)

-

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

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Device Record Status

Public Device Record Key

4d6df8bf-3855-4fc4-8166-a3a6f524d94d

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

10845717007303

Quantity per Package

12

Contains DI Package

30845717007307

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON

"VERIDIAN HEALTHCARE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 127