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Renova Spine Kyphoplasty Working Cannula And Trocar Tip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RESWTR1112C-US
Identity
- Trade Name
- RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP EUDAMEDKYPHOPLASTY WORKING CANNULA AND TROCAR TIP FDA UDI
- Model / Reference
- RESWTR1112C-US EUDAMEDRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP FDA UDI
- Description
- KYPHOPLASTY WORKING CANNULA AND TROCAR TIP FDA UDI
Identifiers
- Catalog Number
- RESWTR1112C-US FDA UDI
- Primary DI / UDI-DI
- 08033860034764 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860034764 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 — 10 Gauge FDA UDILength — 120 Millimeter FDA UDI
Renova Spine Kyphoplasty Working Cannula And Trocar Tip by Biopsybell Srl — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 8033860KYPFT05A9T | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860KYPFT05A9T | 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 31b75566-60db-4dc2-8b2c-f3e972229223 61 fields · synced Sep 30, 2026
- FDA UDI 7ca10289-e48a-4e04-88cf-74a19a172259 37 fields · synced May 30, 2026
- EUDAMED 9348700e-6f5b-49fe-b3a5-11084767b6fc 61 fields · synced Jul 9, 2026