NA - CWF1005, electrode pad, white foam - GMDASZ manufacturing Co., Ltd.

Duns Number:529401134

Device Description: CWF1005, electrode pad, white foam

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

NA

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K160138,K160138,K160138

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

ce6b1797-d659-4980-b573-3bcbf4185cb4

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 19, 2017

Additional Identifiers

Package DI Number

06970341677367

Quantity per Package

420

Contains DI Package

06970341670320

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

paper carton

"GMDASZ MANUFACTURING CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24