NA - Electrode lead 3, snap, AHA - NIHON KOHDEN CORPORATION

Duns Number:690568050

Device Description: Electrode lead 3, snap, AHA

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More Product Details

Catalog Number

BR-943PA

Brand Name

NA

Version/Model Number

BR-943PA

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

DRG

Product Code Name

TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Device Record Status

Public Device Record Key

dd0271c0-79d1-4334-8349-07d651c2a93f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 19, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NIHON KOHDEN CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 461