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Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SST201010SL
Identity
- Trade Name
- Radiofrequency (RF) Needle FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
- Device Name
- Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel) EUDAMED20G x 10cm x 10mm Active Tip Sharp RF Needle, No Echogenic Tip, Lubrication Straight, Yellow Cap FDA UDI
- Model / Reference
- SST201010SL EUDAMEDFDA UDI
- Description
- 20G x 10cm x 10mm Active Tip Sharp RF Needle, No Echogenic Tip, Lubrication Straight, Yellow Cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- +M661SST201010SL% EUDAMEDM661SST201010 FDA UDI
- Basic UDI-DI
- ++M661Inst2AWT EUDAMED
- 510(k) Number
- K032196 FDA UDI
- FDA Product Code
- GXI FDA UDI
- EMDN Code
- A019099 NEEDLES FOR OTHER PROCEDURES - OTHER 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
- 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel) by Spectra Medical Devices, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED…
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 | ++M661Inst2AWT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Spectra Medical Devices, LLC
- EUDAMED SRN
- US-MF-000008491
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 3a4a58bd-59a9-4936-a6ae-34127ee4eefb 61 fields · synced Jul 10, 2026
- FDA UDI 641e9865-a94a-40f9-9a5f-5be2d164f6c0 34 fields · synced May 30, 2026