Identity
- Trade Name
- Neuropen Monofilaments 10g FDA UDI
- Generic Name
- Pressure algometer/aesthesiometer, mechanical FDA UDI
- Device Name
- Monofilaments for neuropathy screening FDA UDI
- Model / Reference
- NT 0104 FDA UDI
- Description
- Monofilaments for neuropathy screening FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00384700104016 FDA UDI
- FDA Product Code
- GXB FDA UDI
- GMDN Term
- Pressure algometer/aesthesiometer, mechanical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.1500 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pressure algometer/aesthesiometer, mechanical
Neuropen Monofilaments 10g by Owen Mumford Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pressure algometer/aesthesiometer, mechanical.
- DARCO® Monofilament Tester — DARCO International, Inc. · Class I
- Luneau — LUNEAU TECHNOLOGY OPERATIONS · Class I
- DARCO® Foot Filament — DARCO International, Inc. · Class I
- Neuropen — OWEN MUMFORD LIMITED · Class I
- Neurotips — OWEN MUMFORD LIMITED · Class I
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
- Owen Mumford Limited
Sources (1)
- FDA UDI e3f400a3-0669-42f7-9ef3-928cb0eec3fd 35 fields · synced Jun 6, 2026