4" x 7" pigtail electrode - 4" x 7" pigtail electrode - BIOMEDICAL LIFE SYSTEMS, INC.

Duns Number:116956807

Device Description: 4" x 7" pigtail electrode

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More Product Details

Catalog Number

EERC400700

Brand Name

4" x 7" pigtail electrode

Version/Model Number

EERC400700

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)

-

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

7c2de414-5afb-4c55-afc3-d527a683e9d6

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10857771003313

Quantity per Package

10

Contains DI Package

00857771003316

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner pack

"BIOMEDICAL LIFE SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 80