AccessGUDID - DEVICE: HydroSteer™ (05414734055123)

GUDID

Device Identifier (DI) Information

Brand Name: HydroSteer™
Version or Model: 405074
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 405074
Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Primary DI Number: 05414734055123
Issuing Agency: GS1
Commercial Distribution End Date: June 29, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040960379 *Terms of Use

Device Description: Guidewires

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: No 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
Special Storage Condition, Specify: STORE IN A COOL, DARK, DRY PLACE.

Clinically Relevant Size

[?]

Size Type Text
Length: 180 Centimeter
Outer Diameter: 0.038 Inch

Device Record Status

Public Device Record Key: bddd6e67-bf42-401d-a7cd-a597689ec1d9
Public Version Date: September 21, 2020
Public Version Number: 5
DI Record Publish Date: September 14, 2015