Identity
- Trade Name
- AxoTouch™ Two-Point Discriminator FDA UDI
- Generic Name
- Two-point aesthesiometer FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 2PDGA1 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850828007036 FDA UDI
- FDA Product Code
- GWI FDA UDI
- GMDN Term
- Two-point aesthesiometer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.1200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Two-point aesthesiometer
AxoTouch™ Two-Point Discriminator by AxoGen Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Two-point aesthesiometer.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AxoGen Corporation
Sources (1)
- FDA UDI 00902400-0602-4cc2-932e-46b3eaa15c54 34 fields · synced May 30, 2026