Identity
- Trade Name
- DARCO® Foot Filament FDA UDI
- Generic Name
- Pressure algometer/aesthesiometer, mechanical FDA UDI
- Model / Reference
- FF FDA UDI
Identifiers
- Catalog Number
- FF FDA UDI
- Primary DI / UDI-DI
- 00609271000094 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pressure algometer/aesthesiometer, mechanical
DARCO® Foot Filament by DARCO International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pressure algometer/aesthesiometer, mechanical.
- Neuropen — OWEN MUMFORD LIMITED · Class I
- Neuropen Monofilaments 10g — OWEN MUMFORD LIMITED · Class I
- Luneau — LUNEAU TECHNOLOGY OPERATIONS · Class I
- Neurotips — OWEN MUMFORD LIMITED · Class I
- DARCO® Monofilament Tester — DARCO International, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DARCO International, Inc.
Sources (1)
- FDA UDI 9086ac66-c783-4f8b-a7ad-4b48382d8c52 33 fields · synced Jun 9, 2026