AccessGUDID - DEVICE: Guidewire (00886333211593)

GUDID

Device Identifier (DI) Information

Brand Name: Guidewire
Version or Model: 395509
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 395509
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333211593
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Guidewire 21/150/FC/ST

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?
35094	Cardiac/peripheral vascular guidewire, single-use	A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQX	Wire, Guide, Catheter

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Device Size Text, specify: .021" x 150cm

Device Record Status

Public Device Record Key: e9af5de3-ce2d-48b0-9719-347e4244af2a
Public Version Date: April 16, 2024
Public Version Number: 3
DI Record Publish Date: September 12, 2016