← Back to catalogue
Renova Spine Classic Access System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RES0812001L
Identity
- Trade Name
- RENOVA SPINE CLASSIC ACCESS SYSTEM EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- RENOVA SPINE CLASSIC ACCESS SYSTEM EUDAMEDKYPHOPLASTY SYSTEMS EUDAMEDKYPHOPLASTY CLASSIC ACCESS BONE KIT FDA UDI
- Model / Reference
- RES0812001L EUDAMEDRENOVA SPINE CLASSIC ACCESS SYSTEM FDA UDI
- Description
- KYPHOPLASTY CLASSIC ACCESS BONE KIT FDA UDI
Identifiers
- Catalog Number
- RES0812001L FDA UDI
- Primary DI / UDI-DI
- 08033860018825 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860018825 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 Classic Access System by Biopsybell Srl — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-08033860018825 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860018825 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED 13d977aa-8b76-4a25-a856-5b88685c7823 61 fields · synced Jun 19, 2026
- EUDAMED b24920ea-19b3-4dc6-a3bb-2eaaa193193a 61 fields · synced May 19, 2026
- FDA UDI ba24cc25-c019-4312-9775-bc2bca4981c1 36 fields · synced May 30, 2026