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Renova Spine Kyphoplasty Working Cannula And Diamond Tip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RESWD1115C
Identity
- Trade Name
- RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP EUDAMEDKYPHOPLASTY WORKING CANNULA AND DIAMOND TIP FDA UDI
- Model / Reference
- RESWD1115C EUDAMEDRENOVA SPINE WORKING CANNULA AND DIAMOND TIP FDA UDI
- Description
- KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP FDA UDI
Identifiers
- Catalog Number
- RESWD1115C FDA UDI
- Primary DI / UDI-DI
- 08033860015374 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860015374 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 — 11 Gauge FDA UDILength — 15 Centimeter FDA UDI
Renova Spine Kyphoplasty Working Cannula And Diamond 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 6ff1a7bc-5e14-42a0-bb2b-5fa2fba06dfe 61 fields · synced Jul 11, 2026
- EUDAMED 69176caa-b7ae-4e89-bd7e-84b2b64101ba 61 fields · synced May 18, 2026
- FDA UDI 5ce88e9a-5917-43f5-83b7-e9788cc41545 36 fields · synced May 30, 2026