Coaxial Interventional Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Coaxial Interventional Needle FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Coaxial Interventional Needle EUDAMEDThis needle is intended for puncture and injection. FDA UDI
- Model / Reference
- Coaxial Interventional Needle EUDAMEDKIM22/15 EUDAMEDFDA UDI
- Description
- This needle is intended for puncture and injection. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04262410680081 EUDAMEDFDA UDI
- Basic UDI-DI
- 426241068KIRKIM94 EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS EUDAMED
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany 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
No
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
No
Dimensions & Sizes
- Size
- Length — 150 Millimeter FDA UDINeedle Gauge — 22 Gauge FDA UDI
Category: Diskectomy system, percutaneous, automatic
Coaxial Interventional Needle by ITP Innovative Tomography Products GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Diskectomy system, percutaneous, automatic.
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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 | 426241068KIRKIM94 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ITP Innovative Tomography Products GmbH
- EUDAMED SRN
- DE-MF-000008634
Sources (2)
- EUDAMED 9987505c-5618-4b2b-bf17-f0060b80e767 61 fields · synced Aug 2, 2026
- FDA UDI aaaa0b2d-1804-4d39-95ac-98466b947331 34 fields · synced May 30, 2026