AxoTouch™ Two-Point Discriminator - The AxoTouch™ Two-Point Discriminator tool is a - AXOGEN CORPORATION

Duns Number:113424464

Device Description: The AxoTouch™ Two-Point Discriminator tool is a set of two aluminum discs each containing The AxoTouch™ Two-Point Discriminator tool is a set of two aluminum discs each containing a series of prongs spaced between 2 to 15 millimeters apart. Additionally, 20 and 25 millimeter spacing is also provided. A circular depression on either side of the disc allows ease of rotation. The discs can be rotated between a single prong for testing one-point and any of the other spaced prongs for testing two-point intervals with ease.Use the AxoTouch™ Two-Point Discriminator tool to measure the innervation density of any surface area of the skin. The discs are useful for measuring sensation after a nerve injury, following the progression of a repaired nerve, and during the evaluation of a person with a possible nerve injury, such as nerve division or nerve compression.

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More Product Details

Catalog Number

-

Brand Name

AxoTouch™ Two-Point Discriminator

Version/Model Number

2PDGA1

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"

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For Single-Use

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Prescription Use (Rx)

-

Over the Counter (OTC)

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Kit

-

Combination Product

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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GWI

Product Code Name

Discriminator,Two-Point

Device Record Status

Public Device Record Key

00902400-0602-4cc2-932e-46b3eaa15c54

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AXOGEN CORPORATION" 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. 2