Identity
- Trade Name
- ViveSole FDA UDI
- Generic Name
- Toe separator FDA UDI
- Device Name
- Triple Toe Splint FDA UDI
- Model / Reference
- INS1028TRP FDA UDI
- Description
- Triple Toe Splint FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810041981073 FDA UDI
- FDA Product Code
- FMP FDA UDI
- GMDN Term
- Toe separator 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
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
No
FDA UDI
Category: Toe separator
ViveSole by Vive Health Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Toe separator.
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- Antibacterial Gel Toe Spreader, Large, 6pcs/bag — SILIPOS Holding LLC · Class I
- Antibacterial Gel Toe Spreader, Medium, 6pcs/bag — SILIPOS Holding LLC · Class I
- Therastep Gel Toe Spacers, French/English, 2pcs/blister — SILIPOS Holding LLC · Class I
- Softzone Gel Toe Separator, Large, Wide, Bulk, 100pcs/bag — SILIPOS Holding LLC · Class I
- DARCO® GTS™ Great Toe Splint — 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
- Vive Health Llc
Sources (1)
- FDA UDI f8087318-23ec-44f1-955b-8b9e5b463f52 33 fields · synced May 30, 2026