BIOPROTECH INC. - SG15G: Ground, EMG Surface Electrode, 40x48mm, - BIOPROTECH INC.

Duns Number:688460539

Device Description: SG15G: Ground, EMG Surface Electrode, 40x48mm, Cloth, Hydrogel

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More Product Details

Catalog Number

-

Brand Name

BIOPROTECH INC.

Version/Model Number

SG15G

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153019,K153019,K153019

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

f8d6ee15-7fae-487f-b33e-b3bac05904d7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 18, 2016

Additional Identifiers

Package DI Number

28809083940991

Quantity per Package

10

Contains DI Package

18809083940994

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case

"BIOPROTECH INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 53