Identity
- Trade Name
- ESTCARBON FDA UDI
- Generic Name
- Orthotic insole, prefabricated, non-antimicrobial FDA UDI
- Device Name
- Recovery Carbon Fiber Insole, W12-12.5/M11-11.5 (10.94 inch) FDA UDI
- Model / Reference
- P1094 FDA UDI
- Description
- Recovery Carbon Fiber Insole, W12-12.5/M11-11.5 (10.94 inch) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04744946011077 FDA UDI
- FDA Product Code
- KYS FDA UDI
- GMDN Term
- Orthotic insole, prefabricated, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6280 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthotic insole, prefabricated, non-antimicrobial
Estcarbon by Erismet OU — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MEDI — MEDI MANUFACTURING, INC. · Class I
- Iloiset Varpaat Varvastuppi S/M — Suomen Hoitolatukku Tuonti Oy · 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
- Erismet OU
Sources (1)
- FDA UDI 79a123b2-0476-452a-ab60-44b0a26d87e2 34 fields · synced May 30, 2026