Technomed Europe - Reusable Shielded Cable, for concentric and - Technomed Engineering B.V.

Duns Number:418415568

Device Description: Reusable Shielded Cable, for concentric and single fiber EMG needle electrode, 5 pole DIN Reusable Shielded Cable, for concentric and single fiber EMG needle electrode, 5 pole DIN connector

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More Product Details

Catalog Number

-

Brand Name

Technomed Europe

Version/Model Number

TE/D64-551

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

IKD

Product Code Name

Cable, Electrode

Device Record Status

Public Device Record Key

cabda6bb-1ab6-4493-a5a8-49665ff8886a

Public Version Date

March 29, 2018

Public Version Number

2

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