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Bone Cement Delivery System
EUDAMEDFDA UDIClass I (EU MDR)
Ref FG8115Model FG8105, FG8108, FG8110, FG8115, FG8120, FG8210, FG8310, FG8215, FG831
Identity
- Trade Name
- KMC Bone Cement Delivery System FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- Bone Cement Delivery System EUDAMEDKMC Bone Cement Delivery System FDA UDI
- Model / Reference
- FG8105, FG8108, FG8110, FG8115, FG8120, FG8210, FG8310, FG8215, FG831 EUDAMEDFG8115 EUDAMEDFDA UDI
- Description
- KMC Bone Cement Delivery System FDA UDI
Identifiers
- Catalog Number
- FG8115 FDA UDI
- Primary DI / UDI-DI
- 06938695581150 EUDAMEDFDA UDI
- Basic UDI-DI
- 69386955HDKB EUDAMED
- Direct Marketing DI
- 06938695581150 EUDAMED
- FDA Product Code
- OAR FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Bone Cement Delivery System by Shanghai Kinetic Medical Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69386955HDKB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Kinetic Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017688
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 73ad43ca-2052-4e96-a37c-c8a38e82bcf6 61 fields · synced May 29, 2026
- FDA UDI a590a178-21be-4a32-b028-c161d64c7a07 37 fields · synced May 29, 2026