AccessGUDID - DEVICE: RFTL Sono (04048223071069)

GUDID

Device Identifier (DI) Information

Brand Name: RFTL Sono
Version or Model: 001175-11D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001175-11D
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223071069
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: RFTL Sono 20G x 52,6 mm with Cornerstone reflectors

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
Prescription Use (Rx):	No
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?
58739	Percutaneous radio-frequency ablation probe cannula, single-use	A rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (RF) ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXI	Probe, radiofrequency lesion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060397	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 20.0 Gauge
Length: 52.6 Millimeter

Device Record Status

Public Device Record Key: 131ef249-9b7f-4cb7-84e5-e20dc54988b0
Public Version Date: December 01, 2025
Public Version Number: 2
DI Record Publish Date: January 30, 2025