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Coaxial Interventional Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref KIM22/07Model Coaxial Interventional NeedleRef KIM15/09TRef KIM15/04TRef KIM18/10TRef KIM18/15TRef KIM18/20Ref KIM15/14TRef KIR21/10Ref KIM18/10Ref KIM16/14TRef KIR21/15Ref KIM18/15Ref KIR23/07NRef KIM20/20Ref KIM13/14TRef KIR23/15Ref KIR23/10
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 EUDAMEDKIM22/07 EUDAMEDKIM18/15T EUDAMEDFDA UDIKIM15/14T EUDAMEDFDA UDIKIM13/14T EUDAMEDFDA UDIKIM20/20 EUDAMEDFDA UDIKIM18/15 EUDAMEDFDA UDIKIM16/14T EUDAMEDFDA UDIKIM18/10T EUDAMEDFDA UDIKIM18/20 EUDAMEDFDA UDIKIM15/09T EUDAMEDFDA UDIKIM18/10 EUDAMEDFDA UDIKIM15/04T EUDAMEDFDA UDIKIR21/10 EUDAMEDKIR21/15 EUDAMEDKIR23/07N EUDAMEDKIR23/15 EUDAMEDKIR23/10 EUDAMED
- Description
- This needle is intended for puncture and injection. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04262410680043 EUDAMED04262410680241 EUDAMEDFDA UDI04262410680364 EUDAMEDFDA UDI04262410680456 EUDAMEDFDA UDI04262410680142 EUDAMEDFDA UDI04262410680180 EUDAMEDFDA UDI04262410680302 EUDAMEDFDA UDI04262410680227 EUDAMEDFDA UDI04262410680203 EUDAMEDFDA UDI04262410680340 EUDAMEDFDA UDI04262410680166 EUDAMEDFDA UDI04262410680326 EUDAMEDFDA UDI04262410680593 EUDAMED04262410680630 EUDAMED04262410680531 EUDAMED04262410680579 EUDAMED04262410680555 EUDAMED
- 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
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 150 Millimeter FDA UDINeedle Gauge — 18 Gauge FDA UDILength — 144 Millimeter FDA UDINeedle Gauge — 15 Gauge FDA UDINeedle Gauge — 13 Gauge FDA UDINeedle Gauge — 20 Gauge FDA UDILength — 200 Millimeter FDA UDINeedle Gauge — 16 Gauge FDA UDILength — 100 Millimeter FDA UDILength — 94 Millimeter FDA UDILength — 44 Millimeter FDA UDI
Coaxial Interventional Needle by ITP Innovative Tomography Products GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 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 (28)
- EUDAMED 34302db3-bda1-4abe-abf8-1ad22a42f7a1 61 fields · synced Aug 4, 2026
- FDA UDI 19dde6d0-8be7-40ee-a037-5fcc0bf1038a 34 fields · synced May 29, 2026
- FDA UDI 51eb165c-ad6b-4aea-99d7-8f597f50bdee 34 fields · synced May 29, 2026
- FDA UDI 6b89b017-d684-4b98-820d-d8d35cf884d5 34 fields · synced May 29, 2026
- FDA UDI 717397e2-4332-44c4-b080-b749e030f55a 34 fields · synced May 29, 2026
- FDA UDI 42e532c1-f153-4058-aa25-242258ea05d3 34 fields · synced May 30, 2026
- FDA UDI 3ec6158b-6f80-4344-a2ab-bb87ed28ce62 34 fields · synced May 30, 2026
- FDA UDI bc06f429-63d9-4cca-ac62-0fe5559d19da 34 fields · synced May 30, 2026
- FDA UDI 85847929-7e53-48f9-94fd-1b6d0abb8f84 34 fields · synced May 30, 2026
- FDA UDI 8c8fd064-f614-4992-bebc-b984a07afda8 34 fields · synced May 30, 2026
- FDA UDI 11b53376-4129-4f05-b46b-c7a94afa7552 34 fields · synced May 30, 2026
- FDA UDI f3393f42-6692-4085-b2e7-003de92290e9 34 fields · synced May 30, 2026
- EUDAMED 7ea82bc2-e389-4edb-8493-303ce3264856 61 fields · synced Jul 8, 2026
- EUDAMED f322aa68-f68a-47b8-a481-d7f67be520d9 61 fields · synced Jul 9, 2026
- EUDAMED 873c1ee8-20e1-416c-bf8d-7f94108bf582 61 fields · synced Jul 9, 2026
- EUDAMED f486f73d-503e-4148-b7db-99320c140f4b 61 fields · synced Jul 10, 2026
- EUDAMED 6a5a6fcd-6220-4b89-89e9-4e25330778bd 61 fields · synced Jul 10, 2026
- EUDAMED 053949f8-6bb5-4930-baa1-6f52f3e2b10b 61 fields · synced Jul 10, 2026
- EUDAMED 260cad7f-690e-43b3-ac66-ca7a48bf7606 61 fields · synced Jul 12, 2026
- EUDAMED 9e72c652-347d-42f8-a07d-98ba8a1fbdc0 61 fields · synced Jul 12, 2026
- EUDAMED cfae6c56-3187-4640-ae7b-54b59252e42e 61 fields · synced Jul 17, 2026
- EUDAMED 236e7063-6b0f-4ccc-8f77-472165177f00 61 fields · synced Jul 19, 2026
- EUDAMED b1828236-18c4-459d-8942-e27b47d43902 61 fields · synced Jul 23, 2026
- EUDAMED 9779db8d-4f44-4f9e-a46b-d910074d4ade 61 fields · synced Jul 23, 2026
- EUDAMED 8b041e79-3ab8-4fc0-99f5-71d869a29749 61 fields · synced Jul 26, 2026
- EUDAMED f3619999-29f0-4b32-be15-7c392dd3e8fc 61 fields · synced Jul 27, 2026
- EUDAMED 7cf861a7-6741-4280-be51-cbab6de207b0 61 fields · synced Aug 3, 2026
- EUDAMED cd246a8d-cfb7-442e-9879-ded456d7baa0 61 fields · synced Aug 4, 2026