AxoTouch™ Two-Point Discriminator

Basic Information

• Brand Name: AxoTouch™ Two-Point Discriminator
• Primary DI: 10850828007036
• Version / Model: 2PDGA1
• Company Name: AXOGEN CORPORATION
• Labeler DUNS: 113424464
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 00902400-0602-4cc2-932e-46b3eaa15c54

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWI	Discriminator,Two-Point	Neurology	882.1200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47165	Two-point aesthesiometer	A manual stimulator designed to determine tactile sensibility by testing a patient's two-point touch discrimination. It is typically a two-branched instrument joined at the top by a pivot (compass-like), with two points that are applied to the skin to test touch discrimination. The device is typically used during physical examinations for detecting peripheral neuropathy and/or in diabetes mellitus or leprosy diagnostics. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850828007036	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]