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Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref S-11SMD-MSS-BRef S-11SMD-SSH-BCRef SST201505NCRef SST221010NCRef SES22100SLRef SST201510NCRef SST221005ECRef SST201005NCRef SST221005NCRef SST201005EC
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 5mm Active Tip, Sharp RF Needle, Echogenic Tip, No Lubrication, Straight, Yellow Cap FDA UDI
- Model / Reference
- S-11SMD-MSS-B EUDAMEDS-11SMD-SSH-BC EUDAMEDSST201505NC EUDAMEDSST221010NC EUDAMEDSES22100SL EUDAMEDSST201510NC EUDAMEDSST221005EC EUDAMEDSST201005NC EUDAMEDSST221005NC EUDAMEDSST201005EC EUDAMEDFDA UDI
- Description
- 20G x 10cm x 5mm Active Tip, Sharp RF Needle, Echogenic Tip, No Lubrication, Straight, Yellow Cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- +M661S11SMDMSSB0 EUDAMED+M661S11SMDSSHBC7 EUDAMED+M661SST201505NC. EUDAMED+M661SST221010NCU EUDAMED+M661SES22100SLS EUDAMED+M661SST201510NCX EUDAMED+M661SST221005ECP EUDAMED+M661SST201005NCW EUDAMED+M661SST221005NCY EUDAMED+M661SST201005ECN EUDAMEDM661SST201005 FDA UDI
- Basic UDI-DI
- ++M661Inst2AWT EUDAMED
- 510(k) Number
- K032196 FDA UDI
- FDA Product Code
- GXI FDA UDI
- EMDN Code
- V010101 SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDA019099 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 (11)
- EUDAMED 5e317fcd-09d5-4e29-96e1-ae0bc1187de0 61 fields · synced Aug 1, 2026
- EUDAMED e594eb25-e2a8-461d-91be-18c8196ab519 61 fields · synced May 17, 2026
- EUDAMED 7696949c-7052-4beb-b845-ff922be8714a 61 fields · synced May 17, 2026
- EUDAMED 06bce91e-92f9-4f4c-b50b-7e43b702d338 61 fields · synced May 18, 2026
- EUDAMED 4f95c58d-a5ea-485e-9bd9-ac629773beac 61 fields · synced May 18, 2026
- EUDAMED f4103087-8e35-426b-9e71-af7f1e12cb0c 61 fields · synced May 18, 2026
- EUDAMED 38ad6705-fb6f-457d-8201-3778035de845 61 fields · synced May 18, 2026
- EUDAMED 72197663-d7ac-473e-91de-a2e7b6525ae4 61 fields · synced May 18, 2026
- EUDAMED ba3f80b0-227a-43a9-8e6f-e5df8eda0385 61 fields · synced May 19, 2026
- EUDAMED b3376502-8edd-4cd8-8d15-ff389363a48a 61 fields · synced May 19, 2026
- FDA UDI 52fb81e7-4894-47b8-9fca-6d74d5362505 34 fields · synced May 30, 2026