2x4" Rectangle Fabric Electrode - 2x4" rectangle white non-woven fabric cutaneous - ELITE MEDICAL SUPPLY OF NY

Duns Number:608469891

Device Description: 2x4" rectangle white non-woven fabric cutaneous hydrogel electrode, package contains 4 ind 2x4" rectangle white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes.

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More Product Details

Catalog Number

-

Brand Name

2x4" Rectangle Fabric Electrode

Version/Model Number

SF50100WP

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)

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

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

2dd60f99-88d4-4f20-8479-658e6c851395

Public Version Date

November 14, 2018

Public Version Number

1

DI Record Publish Date

October 14, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELITE MEDICAL SUPPLY OF NY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4