AccessGUDID - DEVICE: NA (07613327118582)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0406840215
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0406840215
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327118582
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: CVD Cannula

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

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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 probe cannula, single-use	A sterile rigid tube designed to provide body tissue access through its lumen for a radio-frequency (RF) probe during 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.

GMDN Preferred Term Name

GMDN Definition

Radio-frequency ablation system probe cannula, single-use

A sterile rigid tube designed to provide body tissue access through its lumen for a radio-frequency (RF) probe during 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.

FDA Product Code

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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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter: 1.25 Millimeter
Device Size Text, specify: Distal Length: 150.0 Millimeter
Needle Gauge: 18.0 Gauge
Length: 167.9 Millimeter
Device Size Text, specify: Neck Length: 5.0 Millimeter

Device Record Status

Public Device Record Key: 5e3951db-fabf-4189-89f2-7f5a1aff9fe7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016