AccessGUDID - DEVICE: SYNCHRO 14 (07613252186953)

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Device Identifier (DI) Information

Brand Name: SYNCHRO 14
Version or Model: M00313320
Catalog Number: 1332
Company Name: Stryker Corporation

Primary DI Number: 07613252186953
Issuing Agency: GS1
Device Count: 1

Device Description: Neuro Guidewire with Hydrophilic Coating

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
Cardiac guidewire, single-use	A long, coiled, sterile wire intended to be percutaneously placed into the vasculature, typically via the femoral artery, to function as a guide for the introduction, positioning, and/or operation of a cardiac catheter or a pacing lead into the ventricles or vessels of the heart. It is typically made of stainless steel, with or without coating (coating facilitates movement), and is available in a variety of distal tip designs. It is used during percutaneous transluminal coronary angioplasty (PTCA) and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Cardiac guidewire, single-use

A long, coiled, sterile wire intended to be percutaneously placed into the vasculature, typically via the femoral artery, to function as a guide for the introduction, positioning, and/or operation of a cardiac catheter or a pacing lead into the ventricles or vessels of the heart. It is typically made of stainless steel, with or without coating (coating facilitates movement), and is available in a variety of distal tip designs. It is used during percutaneous transluminal coronary angioplasty (PTCA) and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
DQX	WIRE, GUIDE, CATHETER

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
Special Storage Condition, Specify: Store in cool, dry, dark place.

Clinically Relevant Size

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Size Type Text
Length: 300.0 Centimeter
Outer Diameter: 0.014 Inch

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 21, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: SYNCHRO 14 (07613252186953)