AccessGUDID - DEVICE: RFTL (14048223014209)

GUDID

Device Identifier (DI) Information

Brand Name: RFTL
Version or Model: 001165-22C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 001165-22C
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223014209
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2025
Device Count: 25
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: RFTL 18G x 98,6mm, stimulation tip 10mm, grinding 15°,

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":	Yes
For Single-Use:	Yes
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?
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 [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1d6ec3e9-ec0a-431d-9e72-fa022339b206
Public Version Date: March 17, 2025
Public Version Number: 6
DI Record Publish Date: September 01, 2016