Identity
- Trade Name
- DARCO® PegContour™ Insole FDA UDI
- Generic Name
- Orthotic insole, prefabricated, non-antimicrobial FDA UDI
- Device Name
- ML Blue/Grey for MedSurg/-Pro®, Relief Dual®/Plus, Relief Insert ® Walker FDA UDI
- Model / Reference
- PCI-M3-L FDA UDI
- Description
- ML Blue/Grey for MedSurg/-Pro®, Relief Dual®/Plus, Relief Insert ® Walker FDA UDI
Identifiers
- Catalog Number
- PCI-M3-L FDA UDI
- Primary DI / UDI-DI
- 00609271166165 FDA UDI
- FDA Product Code
- FMP FDA UDI
- GMDN Term
- Orthotic insole, prefabricated, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6450 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: Orthotic insole, prefabricated, non-antimicrobial
DARCO® PegContour™ Insole by Darco (Europe) GmbH — 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
- Darco (Europe) GmbH
Sources (1)
- FDA UDI 6d054f45-8937-4dcf-b410-eb5b1156e05e 34 fields · synced Jun 1, 2026