ACP High Conductivity Electrodes 2X4 - TENS Electrodes - ACCELERATED CARE PLUS CORP

Duns Number:828331616

Device Description: TENS Electrodes

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More Product Details

Catalog Number

-

Brand Name

ACP High Conductivity Electrodes 2X4

Version/Model Number

21227

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"

Yes

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

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

45024fca-e228-46d4-af36-13889feb5aa5

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

August 02, 2016

Additional Identifiers

Package DI Number

10858703006167

Quantity per Package

10

Contains DI Package

00858703006160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ACCELERATED CARE PLUS CORP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9