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Renova Spine Kyphoplasty Working Cannula And Expander
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RESWT0812C
Identity
- Trade Name
- RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND EXPANDER EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND EXPANDER EUDAMEDKYPHOPLASTY SYSTEMS EUDAMEDKYPHOPLASTY WORKING CANNULA AND EXPANDER FDA UDI
- Model / Reference
- RESWT0812C EUDAMEDRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND EXPANDER FDA UDI
- Description
- KYPHOPLASTY WORKING CANNULA AND EXPANDER FDA UDI
Identifiers
- Catalog Number
- RESWT0812C FDA UDI
- Primary DI / UDI-DI
- 08033860018931 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860018931 EUDAMED8033860KYPFT05A9T EUDAMED
- FDA Product Code
- OCJ FDA UDI
- EMDN Code
- K010301 SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON EUDAMED
- GMDN Term
- Bone access channel kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 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
Dimensions & Sizes
- Size
- Needle Gauge — 08 Gauge FDA UDI
Renova Spine Kyphoplasty Working Cannula And Expander by Biopsybell Srl — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860018931 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860018931 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED 8ceaae85-7b4e-4995-8942-9a4c6e4aec28 61 fields · synced Jul 18, 2026
- EUDAMED 4eace59e-ed36-4af7-adbc-17f0f996eaf0 61 fields · synced May 19, 2026
- FDA UDI 772c72c9-c111-43b4-b66c-117f4abcc1a7 36 fields · synced May 29, 2026