← Back to catalogue
Confidence Spinal Cement System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 283901913Model CONFIDENCE Spinal Cement System Needles Instruments
Identity
- Trade Name
- CONFIDENCE SPINAL CEMENT SYSTEM EUDAMEDFDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- Confidence Biopsy Needle / Introducer Needle EUDAMEDCONFIDENCE SPINAL CEMENT SYSTEM BIOPSY NEEDLE 13G x 9 Inches FDA UDI
- Model / Reference
- CONFIDENCE Spinal Cement System Needles Instruments EUDAMED283901913 EUDAMEDFDA UDI
- Description
- CONFIDENCE SPINAL CEMENT SYSTEM BIOPSY NEEDLE 13G x 9 Inches FDA UDI
Identifiers
- Catalog Number
- 283901913 FDA UDI
- Primary DI / UDI-DI
- 10705034209388 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a0009365 EUDAMED
- FDA Product Code
- MJG FDA UDI
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
- GMDN Term
- Body aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
Category: Intraosseous infusion kit
Confidence Spinal Cement System by Medos International Sarl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraosseous infusion kit.
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- ARROW — TELEFLEX INCORPORATED · Class I
- RENOVA SPINE BONE FILLER — BIOPSYBELL SRL · Class IIa
- Spinertome kit — Adria S.r.l. · Class IIb
- Cook — COOK INCORPORATED · Class II
- RENOVA SPINE KYPHOPLASTY TOOL KIT — BIOPSYBELL SRL · Class IIa
- SPASY — Seawon Meditech Co.,Ltd. · Class IIa
- VERTEMAX KYPHOPLASTY TOOL KIT — BIOPSYBELL SRL · Class IIa
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 | 0705034a0009365 | 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
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED b239df5d-0443-46b9-947b-e966b6abde17 61 fields · synced Jul 8, 2026
- FDA UDI 7c7240f0-b102-4e04-8ea8-af648e62cca8 35 fields · synced May 30, 2026