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Vertebroplasty Needle 13G
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T060413Model Vertebroplasty Needles
by Teknimed Sas
Identity
- Trade Name
- Vertebroplasty Needle 13G EUDAMEDVertebroplasty needles FDA UDI
- Generic Name
- Vertebral body cement cannula FDA UDI
- Device Name
- Vertebroplasty Needles EUDAMED
- Model / Reference
- Vertebroplasty Needles EUDAMEDT060413 EUDAMED13G FDA UDI
Identifiers
- Catalog Number
- T060413 FDA UDI
- Primary DI / UDI-DI
- 03760177045767 EUDAMEDFDA UDI
- Basic UDI-DI
- 376017704B32D5 EUDAMED
- FDA Product Code
- OCJ FDA UDI
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
- GMDN Term
- Vertebral body cement cannula FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
Yes
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
Yes
FDA UDI
Category: Intraosseous infusion kit
Vertebroplasty Needle 13G by Teknimed Sas — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376017704B32D5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Teknimed Sas
- EUDAMED SRN
- FR-MF-000001224
Sources (2)
- EUDAMED 1ce0d39e-0f50-4b18-8aca-c92df2725fe6 61 fields · synced Jun 18, 2026
- FDA UDI 49d0361c-bb01-4afd-b006-1cc73150d92b 33 fields · synced May 30, 2026