Identity
- Trade Name
- Orthoset® Cement Cartridge FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- Bone Cement Vacuum Mixing and Delivery System FDA UDI
- Model / Reference
- 1400-2200 FDA UDI
- Description
- Bone Cement Vacuum Mixing and Delivery System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15060238201459 FDA UDI
- FDA Product Code
- KIH FDA UDI
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic cement preparation/delivery kit
Orthoset® Cement Cartridge by Summit Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic cement preparation/delivery kit.
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- StabiliT® — Merit Medical Systems, Inc. · Class II
- CEMEX SYSTEM FAST 70G — Tecres · Class II
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
- Summit Medical, LLC
Sources (1)
- FDA UDI d22024eb-673f-4667-8b60-57f41cc52d4f 34 fields · synced May 30, 2026