Vertebroplasty Needle 13G & Biopsy Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
by Teknimed Sas
Identity
- Trade Name
- Vertebroplasty Needle 13G & Biopsy Needle EUDAMEDVertebroplasty needles FDA UDI
- Generic Name
- Vertebral body cement cannula FDA UDI
- Device Name
- Vertebroplasty Needles EUDAMED
- Model / Reference
- Vertebroplasty Needles EUDAMEDT060413B EUDAMED13G & Biopsy needle FDA UDI
Identifiers
- Catalog Number
- T060413B FDA UDI
- Primary DI / UDI-DI
- 03760177045774 EUDAMEDFDA UDI
- Basic UDI-DI
- 376017704B32D5 EUDAMED
- FDA Product Code
- MJG 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
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Intraosseous infusion kit
Vertebroplasty Needle 13G & Biopsy Needle 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
CE/MDR
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 2e0b0b53-b98f-4e3d-94e1-37119e2748ca 61 fields · synced Jun 20, 2026
- FDA UDI 3877da29-0d75-4358-a2a8-a50545604b37 33 fields · synced May 30, 2026