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IntelliBlate Ximitry Probe Assembly, 13G x 15cm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IB-13DPA15
Identity
- Trade Name
- IntelliBlate Ximitry Probe Assembly, 13G x 15cm EUDAMEDIntelliBlate Ximitry Probe Assembly, 13G x 15cm FDA UDI
- Generic Name
- Microwave ablation system probe, electrically-powered FDA UDI
- Device Name
- IntelliBlate Ximitry Probe Assembly EUDAMEDIntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G/15cm Probe QTY 1 FDA UDI
- Model / Reference
- IB-13DPA15 EUDAMEDIB-XPA-1315 FDA UDI
- Description
- IntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G/15cm Probe QTY 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810563022292 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200146PY EUDAMED
- 510(k) Number
- K240480 FDA UDI
- FDA Product Code
- NEY FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Microwave ablation system probe, electrically-powered FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
IntelliBlate Ximitry Probe Assembly, 13G x 15cm by Varian Medical Systems, Inc — Class IIb — 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 | 089947500200146PY | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000007453
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (2)
- EUDAMED 19660e7f-cb21-4eca-bbd3-073bce76742f 61 fields · synced Jun 18, 2026
- FDA UDI 32d76bef-6e1c-4c4c-8ddb-638bf1b55e4b 34 fields · synced May 30, 2026