Horizon™ - DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: - AMC

Duns Number:080242300

Device Description: DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.0 M TWISTED LEADWI DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.0 M TWISTED LEADWIRE, COLOR GROUP 1 - 20/BOX

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


More Product Details

Catalog Number

-

Brand Name

Horizon™

Version/Model Number

NS-S82020-PT1-20

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

GXZ

Product Code Name

Electrode, Needle

Device Record Status

Public Device Record Key

3063f68e-d9b3-41b2-893e-0888ac0bb532

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 11, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1261