AccessGUDID - DEVICE: AXS Catalyst 6 (07613327012033)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 07613327012033
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042405446 *Terms of Use

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 a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. 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 a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
DQY	CATHETER, PERCUTANEOUS
NRY	CATHETER, THROMBUS RETRIEVER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151667	000
K173841	000

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
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 Record Status

Public Device Record Key: 5b457013-217f-4ae4-a199-1858b80f8c1c
Public Version Date: January 23, 2019
Public Version Number: 6
DI Record Publish Date: September 21, 2016