AccessGUDID - DEVICE: AVANOS (00193493997114)

GUDID

Device Identifier (DI) Information

Brand Name: AVANOS
Version or Model: PMP-20-60C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PMP-20-60C
Company Name: Avanos Medical, Inc.

Primary DI Number: 00193493997114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use
Previous DI: 10680651997118

Device Description: RF Probe, Curved

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):	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?
62025	Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable	A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under x-ray, ultrasound (US) or other external image guidance] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXI	Probe, radiofrequency lesion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002389	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 3e57efef-0179-4791-8a96-ea0cafe83e2c
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: August 25, 2020