UroStream UROS-038150-S

GUDID 10827002591568

UroStream Hydrophilic Wire Guide

COOK INCORPORATED

Gastro-urological guidewire, single-use
Primary Device ID10827002591568
NIH Device Record Key695c4c81-be35-47a1-bda0-905f2c393b83
Commercial Distribution StatusIn Commercial Distribution
Brand NameUroStream
Version Model NumberG59156
Catalog NumberUROS-038150-S
Company DUNS042823948
Company NameCOOK INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
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(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100827002591561 [Primary]
GS110827002591568 [Package]
Contains: 00827002591561
Package: Each [5 Units]
In Commercial Distribution

FDA Product Code

OCYEndoscopic guidewire, gastroenterology-urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-22
Device Publish Date2023-06-14

On-Brand Devices [UroStream]

10827002591599UroStream Hydrophilic Wire Guide
10827002591582UroStream Hydrophilic Wire Guide
10827002591568UroStream Hydrophilic Wire Guide
10827002591551UroStream Hydrophilic Wire Guide
10827002591544UroStream Hydrophilic Wire Guide
10827002591537UroStream Hydrophilic Wire Guide
10827002591520UroStream Hydrophilic Wire Guide
10827002591513UroStream Hydrophilic Wire Guide
10827002591506UroStream Hydrophilic Wire Guide
10827002591490UroStream Hydrophilic Wire Guide

Trademark Results [UroStream]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UROSTREAM
UROSTREAM
90132493 not registered Live/Pending
Cook Medical Technologies LLC
2020-08-24
UROSTREAM
UROSTREAM
85912182 4507836 Live/Registered
Encore, Inc.
2013-04-23

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