Identity
- Trade Name
- MiraColt Generation 4 Seat FDA UDI
- Generic Name
- Core body stabilization/exercise stool FDA UDI
- Device Name
- Generation 4 Adult Seat - Cinnamon FDA UDI
- Model / Reference
- MCE104 FDA UDI
- Description
- Generation 4 Adult Seat - Cinnamon FDA UDI
Identifiers
- Catalog Number
- MCE04SUAC FDA UDI
- Primary DI / UDI-DI
- G612MCE04SUAC1 FDA UDI
- FDA Product Code
- BXB FDA UDI
- GMDN Term
- Core body stabilization/exercise stool FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5380 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
No
FDA UDI
Category: Core body stabilization/exercise stool
MiraColt Generation 4 Seat by Chariot Innovations Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Core body stabilization/exercise stool.
- MiraColt Generation 4 Seat — CHARIOT INNOVATIONS INC · Class I
- MiraColt Generation 4 Seat — CHARIOT INNOVATIONS INC · Class I
- MiraColt Generation 4 Seat — CHARIOT INNOVATIONS 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
- Chariot Innovations Inc
Sources (1)
- FDA UDI c5dbde17-b537-42e3-84bf-3de83bb6f53d 35 fields · synced May 30, 2026