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Epimed International, Inc.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 282-1810Model RF Cannula
Identity
- Trade Name
- Epimed International,Inc. EUDAMEDEpimed FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
- Device Name
- R-F™ Cannula B-Bevel 18g x 10cm w/ 10mm Active Tip FDA UDI
- Model / Reference
- RF Cannula EUDAMED282-1810 EUDAMEDFDA UDI
- Description
- R-F™ Cannula B-Bevel 18g x 10cm w/ 10mm Active Tip FDA UDI
Identifiers
- Catalog Number
- 282-1810 FDA UDI
- Primary DI / UDI-DI
- 00818788022479 EUDAMEDFDA UDI
- Basic UDI-DI
- 081878802RFCannulaRS EUDAMED
- 510(k) Number
- K041021 FDA UDI
- FDA Product Code
- GXI FDA UDI
- EMDN Code
- K02030106 RADIOFREQUENCY SURGERY CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4725 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
Yes
EUDAMED
Measuring Function
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDINeedle Gauge — 18 Gauge FDA UDILength — 10 Millimeter FDA UDI
Epimed International, Inc. by Epimed International, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 081878802RFCannulaRS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Epimed International, Inc.
- EUDAMED SRN
- US-MF-000010774
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 052cbe85-514a-4c87-8dc2-0eee0483f27e 61 fields · synced Jul 19, 2026
- FDA UDI d986a187-e569-462b-8643-23243c10ba97 38 fields · synced May 30, 2026