Identity
- Trade Name
- DARCO® PegAssist™ Insole FDA UDI
- Generic Name
- Pressure-management insole, prefabricated FDA UDI
- Device Name
- WM Blue for MedSurg/-Pro®, Relief Dual®/Plus, Relief Insert ® Walker FDA UDI
- Model / Reference
- PAS-W2 FDA UDI
- Description
- WM Blue for MedSurg/-Pro®, Relief Dual®/Plus, Relief Insert ® Walker FDA UDI
Identifiers
- Catalog Number
- PAS-W2 FDA UDI
- Primary DI / UDI-DI
- 00609271333253 FDA UDI
- FDA Product Code
- FMP FDA UDI
- GMDN Term
- Pressure-management insole, prefabricated 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: Pressure-management insole, prefabricated
DARCO® PegAssist™ Insole by DARCO International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pressure-management insole, prefabricated.
- DARCO® WCS™ / WCS™ Light Insoles — Darco (Europe) GmbH · Class I
- DARCO® Peg-Assist™ Off-loading Insole — DARCO International, Inc. · Class I
- DARCO® Peg-Assist™ Off-loading Insole — DARCO International, Inc. · Class I
- DARCO® PegAssist™ Insole — DARCO International, Inc. · Class I
- DARCO® PegAssist™ Insole — DARCO International, Inc. · Class I
- DARCO® Peg-Assist™ Off-loading Insole — DARCO International, Inc. · Class I
- DARCO® Peg-Assist™ Off-loading Insole — DARCO International, Inc. · Class I
- DARCO® Peg-Assist™ Off-loading Insole — 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 |
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Manufacturer
- Manufacturer
- DARCO International, Inc.
Sources (1)
- FDA UDI 4c821908-2ac8-4fc1-8ecf-44bccfbba954 34 fields · synced Jun 9, 2026