AccessGUDID - DEVICE: NA (07613327118513)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0406815020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0406-815-020
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327118513
Issuing Agency: GS1
Commercial Distribution End Date: July 16, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Monop. Nitinol Electrode

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?
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 [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -34 and 65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 200.0 Millimeter

Device Record Status

Public Device Record Key: 9d548144-472a-41c6-b9cc-f5e3e5d964c5
Public Version Date: July 20, 2023
Public Version Number: 7
DI Record Publish Date: September 23, 2016