Neuroline InojectNeurology Needle Electrodes - Needle Electrode Length: 38 mm (1.5") - Ambu A/S

Duns Number:305682023

Device Description: Needle Electrode Length: 38 mm (1.5") Pre-attached Leadwire: 76 cm (30") Hub Colour: Green

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

74438-45/10

Brand Name

Neuroline InojectNeurology Needle Electrodes

Version/Model Number

74438-45/10

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

-

Product Code Details

Product Code

IKT

Product Code Name

Electrode, needle, diagnostic electromyograph

Device Record Status

Public Device Record Key

0ea0cb22-db75-4fbf-a0f3-6a42d6a895e0

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

05707480001033

Quantity per Package

16

Contains DI Package

05707480022342

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"AMBU A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 309