DEVICE: AXS Catalyst 5 (07613327012019)

Download: XML | JSON

Device Identifier (DI) Information

AXS Catalyst 5
M003IC0581150
IC058115
Stryker Corporation
07613327012019
GS1
1
Distal Access Catheter
CLOSE

Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DQY CATHETER, PERCUTANEOUS
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in cool, dry, dark place.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 115.0 Centimeter
Lumen/Inner Diameter: 0.058 Inch
CLOSE

Device Status

In Commercial Distribution
September 21, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(855)916-3876
NVCustomerService@stryker.com
CLOSE