AXS Catalyst 6 IC060132

GUDID 07613327012033

Distal Access Catheter

Stryker Corporation

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID07613327012033
NIH Device Record Key5b457013-217f-4ae4-a199-1858b80f8c1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAXS Catalyst 6
Version Model NumberM003IC0601320
Catalog NumberIC060132
Company DUNS042405446
Company NameStryker Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com

Device Dimensions

Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter
Lumen/Inner Diameter0.06 Inch
Length132 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327012033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-01-23
Device Publish Date2016-09-21

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07613327634914 - Neptune2024-04-24 SMART DOCKING STATION (120V)
07613327627664 - KNOTILUS+2024-03-15 2.9X12.5MM KNOTILUS+ HIP ANCHOR - PEEK
07613327627701 - KNOTILUS+2024-03-15 2.4X8.9MM KNOTILUS+ HIP ANCHOR - PEEK
07613327623796 - KNOTILUS+2024-03-13 2.4X8.9MM DRILL, HIP
07613327623833 - KNOTILUS+2024-03-13 2.4X8.9MM DRILL, HARD BONE, HIP
07613327634686 - Iconix2024-03-12 Iconix DC Guide for 1.4mm anchor
07613327634693 - Iconix2024-03-12
07613327616675 - SPY2024-03-06
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