UltraPoint - DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE - AMC

Duns Number:080242300

Device Description: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 50 MM NEEDLE, 2 FT. (0.6 M) SIN DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 50 MM NEEDLE, 2 FT. (0.6 M) SINGLE GREEN LEADWIRE 25/Box

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More Product Details

Catalog Number

-

Brand Name

UltraPoint

Version/Model Number

NM-016395

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

K080914,K080914

Product Code Details

Product Code

IKT

Product Code Name

Electrode, Needle, Diagnostic Electromyograph

Device Record Status

Public Device Record Key

daf3070e-dfcf-4af5-b8ef-ab3eb6428f51

Public Version Date

April 24, 2019

Public Version Number

1

DI Record Publish Date

April 16, 2019

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