NA - PG479/50W/US are round-shaped disposable adhesive - FIAB SPA

Duns Number:439770017

Device Description: PG479/50W/US are round-shaped disposable adhesive electrodes with solid conductive gel. Hi

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More Product Details

Catalog Number

PG479/50W/US

Brand Name

NA

Version/Model Number

PG479/50W/US

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

Yes

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

K091163,K091163

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

f02d2c5d-61e5-4146-ae42-9083d10acc55

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

June 12, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FIAB SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 42