Technomed Europe - Reusable Concentric EMG Needle Electrode, Pt/Ir - Technomed Engineering B.V.

Duns Number:418415568

Device Description: Reusable Concentric EMG Needle Electrode, Pt/Ir electrode, red

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More Product Details

Catalog Number

-

Brand Name

Technomed Europe

Version/Model Number

TE/D12-301

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 08, 2021

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

GXZ

Product Code Name

Electrode, Needle

Device Record Status

Public Device Record Key

cc748a47-e860-41f4-ab14-496318f237db

Public Version Date

December 09, 2021

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TECHNOMED ENGINEERING B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 429