Identity
- Trade Name
- KMC Bone Cement Delivery System FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- KMC Bone Cement Delivery System FDA UDI
- Model / Reference
- FG8315 FDA UDI
- Description
- KMC Bone Cement Delivery System FDA UDI
Identifiers
- Catalog Number
- FG8315 FDA UDI
- Primary DI / UDI-DI
- 06938695501516 FDA UDI
- FDA Product Code
- OAR 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
Dimensions & Sizes
- Size
- Length — 60 Centimeter FDA UDIPressure — 440 Pound per Square Inch FDA UDI
Category: Orthopaedic cement preparation/delivery kit
KMC Bone Cement Delivery System by Shanghai Kinetic Medical Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Kinetic Medical Co., Ltd.
Sources (2)
- FDA UDI b5136cd1-f92d-46a7-9105-3a320a6c9a8b 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026