Identity
- Trade Name
- PROLUNGA CURVA EUDAMEDPROLUNGA EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- ACCESSORIES FOR BONE AUGMENTATION MATERIAL INJECTION EUDAMEDPROLUNGA EUDAMEDDevice for cement infusion in the vertebroplasty/kyphoplasty procedure FDA UDI
- Model / Reference
- PRC-001 EUDAMEDPR20 EUDAMEDVERTEBROPLASTY EXTENTION LINES FDA UDI
- Description
- Device for cement infusion in the vertebroplasty/kyphoplasty procedure FDA UDI
Identifiers
- Catalog Number
- PRC-001 FDA UDI
- Primary DI / UDI-DI
- 08033860039417 EUDAMEDFDA UDI08033860041656 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A1S3Z EUDAMEDB-08033860041656 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
- Italy 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
No
FDA UDI
Prolunga Curva by Biopsybell Srl — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860KYPFT05A1S3Z | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8033860KYPFT05A1S3Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (4)
- EUDAMED 1e554167-0496-40c5-b6b1-917737fa2266 61 fields · synced Jul 31, 2026
- EUDAMED fefa70c4-1d61-40b0-a8e0-feabf977f754 61 fields · synced May 18, 2026
- FDA UDI 972409ea-bec6-47a9-9f0f-a1cf2ae9fbc2 35 fields · synced May 30, 2026
- EUDAMED 01abd474-08e4-498d-9e8f-40c368867f07 61 fields · synced Jun 20, 2026