Identity
- Trade Name
- Formthotics FDA UDI
- Generic Name
- Orthotic insole, prefabricated, antimicrobial FDA UDI
- Device Name
- Formthotics Medical Original Single X Soft - M FDA UDI
- Model / Reference
- FM01-OrXsA-Be-ME FDA UDI
- Description
- Formthotics Medical Original Single X Soft - M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09419430006833 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Orthotic insole, prefabricated, antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthotic insole, prefabricated, antimicrobial
Formthotics by Foot Science International Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Foot Science International Limited
Sources (1)
- FDA UDI 85b72d9c-7b03-47dc-b79b-590a2cf0f4b1 33 fields · synced May 30, 2026