Identity
- Trade Name
- DARCO® Relief Insert™ Walker 2.0 Lining FDA UDI
- Generic Name
- Lower-limb orthosis ankle/foot component, mechanical-resistance FDA UDI
- Device Name
- S Blue FDA UDI
- Model / Reference
- RIW2EL-1 FDA UDI
- Description
- S Blue FDA UDI
Identifiers
- Catalog Number
- RIW2EL-1 FDA UDI
- Primary DI / UDI-DI
- 04251853900337 FDA UDI
- FDA Product Code
- NOC FDA UDI
- GMDN Term
- Lower-limb orthosis ankle/foot component, mechanical-resistance FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.3910 FDA UDI
- Commercial Distribution
- Not 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
DARCO® Relief Insert™ Walker 2.0 Lining by Darco (Europe) GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 6372024b-dd61-485f-9b0c-d7998b0e719e 35 fields · synced May 30, 2026