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Spirotome SS‐10‐10
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 05407005001080Model SS‐08‐10
by Bioncise NV
Identity
- Trade Name
- Spirotome SS‐10‐10 EUDAMEDSpirotome FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Device Name
- Spirotome EUDAMEDThe Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 10G (4mm) and length of 100 mm. FDA UDI
- Model / Reference
- SS‐08‐10 EUDAMED05407005001080 EUDAMEDSS1010 FDA UDI
- Description
- The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 10G (4mm) and length of 100 mm. FDA UDI
Identifiers
- Catalog Number
- SS1010 FDA UDI
- Primary DI / UDI-DI
- 05407005001080 EUDAMEDFDA UDI
- Basic UDI-DI
- 5407005001035PU EUDAMED
- 510(k) Number
- K080095 FDA UDI
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
- GMDN Term
- Soft-tissue biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Spirotome SS‐10‐10 by Bioncise NV — 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 | 5407005001035PU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bioncise NV
- EUDAMED SRN
- BE-MF-000000875
Sources (2)
- EUDAMED ec0fe1d2-948a-43af-b925-e34eb479319a 61 fields · synced Jul 18, 2026
- FDA UDI 8c9b6aeb-f043-45aa-a53c-7308c3b10580 35 fields · synced May 30, 2026