Surpass Evolve FDS40025

GUDID 07613327375213

Flow Diverter System

Stryker Corporation

Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent
Primary Device ID07613327375213
NIH Device Record Key049f338a-d791-45d5-a42d-6e11eac1deee
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurpass Evolve
Version Model NumberFDS40025
Catalog NumberFDS40025
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

Device Dimensions

Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter
Lumen/Inner Diameter4 Millimeter
Length25 Millimeter

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327375213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUTIntracranial aneurysm flow diverter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-15
Device Publish Date2020-07-07

On-Brand Devices [Surpass Evolve]

07613327386783Flow Diverter System
07613327386776Flow Diverter System
07613327386769Flow Diverter System
07613327386752Flow Diverter System
07613327386745Flow Diverter System
07613327386738Flow Diverter System
07613327386721Flow Diverter System
07613327386714Flow Diverter System
07613327386707Flow Diverter System
07613327386691Flow Diverter System
07613327386684Flow Diverter System
07613327386677Flow Diverter System
07613327386660Flow Diverter System
07613327386653Flow Diverter System
07613327386646Flow Diverter System
07613327386639Flow Diverter System
07613327386622Flow Diverter System
07613327386615Flow Diverter System
07613327386608Flow Diverter System
07613327386592Flow Diverter System
07613327386585Flow Diverter System
07613327386578Flow Diverter System
07613327386561Flow Diverter System
07613327386554Flow Diverter System
07613327386547Flow Diverter System
07613327386530Flow Diverter System
07613327386523Flow Diverter System
07613327386516Flow Diverter System
07613327386509Flow Diverter System
07613327386493Flow Diverter System
07613327386486Flow Diverter System
07613327385670Flow Diverter System
07613327385663Flow Diverter System
07613327385656Flow Diverter System
07613327385649Flow Diverter System
07613327385632Flow Diverter System
07613327385625Flow Diverter System
07613327375329Flow Diverter System
07613327375312Flow Diverter System
07613327375305Flow Diverter System
07613327375299Flow Diverter System
07613327375282Flow Diverter System
07613327375275Flow Diverter System
07613327375268Flow Diverter System
07613327375251Flow Diverter System
07613327375244Flow Diverter System
07613327375237Flow Diverter System
07613327375220Flow Diverter System
07613327375213Flow Diverter System
07613327375206Flow Diverter System

Trademark Results [Surpass Evolve]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURPASS EVOLVE
SURPASS EVOLVE
87827929 not registered Live/Pending
Stryker Corporation
2018-03-09
SURPASS EVOLVE
SURPASS EVOLVE
87827929 not registered Live/Pending
Stryker European Holdings I, LLC
2018-03-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.