AccessGUDID - DEVICE: SPINERY Generator (00860011603665)

GUDID

Device Identifier (DI) Information

Brand Name: SPINERY Generator
Version or Model: SPINERY
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AXON SRL

Primary DI Number: 00860011603665
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 439154305 *Terms of Use

Device Description: SPINERY Generator (REF: SPINERY) is a RadioFrequency Generator used for parameter control and treatment modulation; equipped with a peristaltic pump intended to allow the flow of a close cooling fluid (sterile saline water) inside RF electrode needles during ablation procedure. A Footswitch, used to control the activation and interruption of the ablation, is provided together with the Generator. A Stainless-Steel rod is also provided to hang up the sterile water bag for used for cooling system circuit.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35156	Percutaneous radio-frequency ablation system generator	An electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223303	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5eca930f-5b81-43c7-86c3-7798fdc27d5a
Public Version Date: June 04, 2024
Public Version Number: 1
DI Record Publish Date: May 27, 2024