SYNCHRO 2 2601

GUDID 04546540688729

Soft Guidewire with Hydrophilic Coating

Stryker Corporation

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID04546540688729
NIH Device Record Keyb1a27b62-8766-4862-9781-0c9f7bee547e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYNCHRO 2
Version Model NumberM00326010
Catalog Number2601
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

Device Dimensions

Outer Diameter0.014 Inch
Length200 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104546540688729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

On-Brand Devices [SYNCHRO 2]

04546540688798Standard Pre-shaped Guidewire with Hydrophilic Coating
04546540688781Standard Guidewire with Hydrophilic Coating
04546540688774Standard Pre-shaped Guidewire with Hydrophilic Coating
04546540688767Standard Guidewire with Hydrophilic Coating
04546540688750Soft Pre-shaped Guidewire with Hydrophilic Coating
04546540688743Soft Guidewire with Hydrophilic Coating
04546540688736Soft Pre-shaped Guidewire with Hydrophilic Coating
04546540688729Soft Guidewire with Hydrophilic Coating

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