AccessGUDID - DEVICE: NA (07613327118513)

GUDID

View all sections | Close all sections

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0406815020
Catalog Number: 0406815020
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327118513
Issuing Agency: GS1
Device Count: 1

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Radio-frequency ablation system	An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

GMDN Preferred Term Name

GMDN Definition

Radio-frequency ablation system

An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

FDA Product Code

[?]

Product Code	Product Code Name
GXI	PROBE, RADIOFREQUENCY LESION

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