Identity
- Trade Name
- DARCO® GentleStep™ Shoe FDA UDI
- Generic Name
- Orthotic shoe, non-customized FDA UDI
- Device Name
- Women's 12.5 / Men's 11 Black Medium width FDA UDI
- Model / Reference
- GS125MB FDA UDI
- Description
- Women's 12.5 / Men's 11 Black Medium width FDA UDI
Identifiers
- Catalog Number
- GS125MB FDA UDI
- Primary DI / UDI-DI
- 00609271231269 FDA UDI
- FDA Product Code
- KNP FDA UDI
- GMDN Term
- Orthotic shoe, non-customized 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
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 shoe, non-customized
DARCO® GentleStep™ Shoe by DARCO International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthotic shoe, non-customized.
- VIVE — VIVE HEALTH LLC · Class I
- DARCO® Relief Dual® + Toe Cap — Darco (Europe) GmbH · Class I
- DARCO® MedSurg Pro® — Darco (Europe) GmbH · Class I
- Position Health® Classic Post-Op Shoe — Walgreen Health Solutions, LLC · Class I
- DARCO® Relief Dual® Plus — Darco (Europe) GmbH · Class I
- DARCO® Relief Dual® Plus — Darco (Europe) GmbH · Class I
- DARCO® WCS™ — Darco (Europe) GmbH · Class I
- Position Health® Classic Post-Op Shoe — Walgreen Health Solutions, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DARCO International, Inc.
Sources (1)
- FDA UDI 186ce2fb-cf82-4585-aada-7c874017755a 34 fields · synced Jun 9, 2026