Identity
- Trade Name
- SPINERY Connections FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe cooling tubing set FDA UDI
- Device Name
- SpineryTM Connections are cooling tubing to connect the needle handle with the cooling solution.The connection provides send and return of sterile saline water from the bag to connected needle. The double connection cooling tube is for use with two bipolar RF needles with a product code of SP-CD. FDA UDI
- Model / Reference
- SP-CD FDA UDI
- Description
- SpineryTM Connections are cooling tubing to connect the needle handle with the cooling solution.The connection provides send and return of sterile saline water from the bag to connected needle. The double connection cooling tube is for use with two bipolar RF needles with a product code of SP-CD. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011603627 FDA UDI
- 510(k) Number
- K223303 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation probe cooling tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Percutaneous radio-frequency ablation probe cooling tubing set
SPINERY Connections by Axon Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation probe cooling tubing set.
- SPINERY Connection — AXON SRL · Class II
Cleared under the same submission
K223303 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Axon Srl
Sources (1)
- FDA UDI b0e37ee6-57ef-4702-aa41-0a0496b605aa 34 fields · synced May 30, 2026