BIONEN - Concentric Needle Electrode for EMG - BIONEN SAS DI BARBARA NENCIONI & C.

Duns Number:444022750

Device Description: Concentric Needle Electrode for EMG

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More Product Details

Catalog Number

-

Brand Name

BIONEN

Version/Model Number

0028113

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

K092973

Product Code Details

Product Code

IKT

Product Code Name

Electrode, Needle, Diagnostic Electromyograph

Device Record Status

Public Device Record Key

2d764bb6-e0f9-4aa2-8844-03262576d819

Public Version Date

October 05, 2018

Public Version Number

1

DI Record Publish Date

September 04, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIONEN SAS DI BARBARA NENCIONI & C." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 17