AXS INFINITY LS PLUS INC-11196-90

GUDID 07613327459203

Long Sheath

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
Primary Device ID07613327459203
NIH Device Record Key88c40acb-f602-40ac-be24-8bcc81f68ae0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAXS INFINITY LS PLUS
Version Model NumberINC-11196-90
Catalog NumberINC-11196-90
Company DUNS042405446
Company NameStryker Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Dimensions

Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch
Length90 Centimeter
Lumen/Inner Diameter0.091 Inch

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327459203 [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 Number3
Public Version Date2019-01-23
Device Publish Date2018-10-08

On-Brand Devices [AXS INFINITY LS PLUS]

07613327459203Long Sheath
07613327459197Long Sheath
07613327459180Long Sheath

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