AccessGUDID - DEVICE: AXS Catalyst 6 (07613327012033)

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Device Identifier (DI) Information

Brand Name: AXS Catalyst 6
Version or Model: M003IC0601320
Catalog Number: IC060132
Company Name: Stryker Corporation

Primary DI Number: 07613327012033
Issuing Agency: GS1
Device Count: 1

Device Description: Distal Access Catheter

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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
Vascular guide-catheter, single-use	A sterile flexible tube intended to be used for the percutaneous transluminal passage and placement of guidewires and/or diagnostic/interventional devices (e.g., pacing leads, balloon dilatation catheter, stent and delivery system, or embolization device) within the vascular system. The guide catheter may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, multi-purpose, hockey stick, renal double curve); it typically has radiopaque markers so that it can be fluoroscopically tracked. It may include disposable introduction devices (e.g., needle, guidewire, dilator). This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Vascular guide-catheter, single-use

A sterile flexible tube intended to be used for the percutaneous transluminal passage and placement of guidewires and/or diagnostic/interventional devices (e.g., pacing leads, balloon dilatation catheter, stent and delivery system, or embolization device) within the vascular system. The guide catheter may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, multi-purpose, hockey stick, renal double curve); it typically has radiopaque markers so that it can be fluoroscopically tracked. It may include disposable introduction devices (e.g., needle, guidewire, dilator). This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
DQY	CATHETER, PERCUTANEOUS

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
Lumen/Inner Diameter: 0.06 Inch
Length: 132.0 Centimeter

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: AXS Catalyst 6 (07613327012033)