TPWT4-2 - 2.0" X 2.0" Square electrode patch in pouch of 4 - Bio Medical Innovations

Duns Number:173358318

Device Description: 2.0" X 2.0" Square electrode patch in pouch of 4 each electrodes.

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More Product Details

Catalog Number

-

Brand Name

TPWT4-2

Version/Model Number

TENS

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

Yes

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

a6ff1db9-9992-4f65-a585-e23506087aa5

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 03, 2016

Additional Identifiers

Package DI Number

30816625020122

Quantity per Package

4

Contains DI Package

10816625020128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"BIO MEDICAL INNOVATIONS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19