AccessGUDID - DEVICE: Radiofrequency (RF) Needle (M661SST221005)

GUDID

Device Identifier (DI) Information

Brand Name: Radiofrequency (RF) Needle
Version or Model: SST221005SL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Spectra Medical Devices, LLC

Primary DI Number: M661SST221005
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118301171 *Terms of Use

Device Description: 22G x 10cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Black Cap

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:	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 [?]
K032196	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a3fc96f5-c4b2-445a-b53b-ebfcce419eff
Public Version Date: June 26, 2024
Public Version Number: 1
DI Record Publish Date: June 18, 2024