Fusion FS-OMNI-ACRO-35-205

GUDID 10827002346014

Fusion Omni Preloaded with Acrobat Wire Guide

COOK INCORPORATED

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID10827002346014
NIH Device Record Key2d169f02-46ec-4100-8899-fa5de8b1244f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFusion
Version Model NumberG34601
Catalog NumberFS-OMNI-ACRO-35-205
Company DUNS079720472
Company NameCOOK INCORPORATED
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 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

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS110827002346014 [Primary]

FDA Product Code

KNSUnit, electrosurgical, endoscopic (with or without accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-07
Device Publish Date2016-09-24

On-Brand Devices [Fusion]

00827002561038Fusion Omni-tome Preloaded Sphincterotome
00827002558151Fusion Omni-tome Preloaded Sphincterotome
00827002558144Fusion Omni-tome Preloaded Sphincterotome
00827002509771Fusion Looptip Wire Guide
00827002509764Fusion Looptip Wire Guide
00827002509757Fusion Looptip Wire Guide
00827002495739Fusion Biliary Dilation Catheter
00827002495722Fusion Biliary Dilation Catheter
00827002495715Fusion Biliary Dilation Catheter
00827002490918Fusion Cytology Brush
00827002486768Fusion Preloaded Omni-tome
00827002486751Fusion Omni-tome
00827002482784Fusion Lithotripsy Extraction Basket
00827002482777Fusion Lithotripsy Extraction Basket
00827002319110Fusion Preloaded Omni-tome
00827002319103Fusion Ultra Short Wire Guide
00827002319059Fusion Wire Guided Extraction Basket
00827002319035Fusion Omni-tome Sphincterotome
10827002315409Fusion Wire Guide Locking Device
00827002315396Fusion Triple Lumen Needle Knife
00827002315389Fusion Extraction Balloon with Multiple Sizing
00827002315372Fusion Extraction Balloon with Multiple Sizing
00827002315334Fusion Triple Lumen Sphincterotome
00827002315327Fusion Biliary Dilation Balloon
00827002315310Fusion Biliary Dilation Balloon
00827002315303Fusion Biliary Dilation Balloon
00827002315297Fusion Biliary Dilation Balloon
00827002315259Fusion Cytology Brush
10827002315225Fusion Wire Guide Locking Device
00827002267268Fusion Ultra Short Wire Guide
10827002573038Fusion Omni Pre-Loaded With Acrobat 2 Wire Guide
10827002573014Fusion Omni Pre-Loaded With Acrobat 2 Wire Guide
10827002347110Fusion Omni Preloaded with Acrobat Wire Guide
10827002346939Fusion Omni Preloaded with Acrobat Wire Guide
10827002346014Fusion Omni Preloaded with Acrobat Wire Guide

Trademark Results [Fusion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FUSION
FUSION
98841130 not registered Live/Pending
Society of Manufacturing Engineers
2024-11-07
FUSION
FUSION
98743428 not registered Live/Pending
Natural Gas Solutions North America, LLC
2024-09-10
FUSION
FUSION
98612710 not registered Live/Pending
ForeverLawn, Inc.
2024-06-21
FUSION
FUSION
98536910 not registered Live/Pending
Tingo Medical Ltd
2024-05-07
FUSION
FUSION
98488506 not registered Live/Pending
Maguire Products, Inc.
2024-04-08
FUSION
FUSION
98441409 not registered Live/Pending
Fladger, Bilal Faheem
2024-03-08
FUSION
FUSION
98441352 not registered Live/Pending
Fladger, Bilal Faheem
2024-03-08
FUSION
FUSION
98414340 not registered Live/Pending
Kreuter Manufacturing Co Inc
2024-02-21
FUSION
FUSION
98370752 not registered Live/Pending
Bearport Minnesota, LLC
2024-01-23
FUSION
FUSION
98360096 not registered Live/Pending
Topgolf Callaway Brands Corp.
2024-01-16
FUSION
FUSION
98331283 not registered Live/Pending
MagScope, LLC
2023-12-26
FUSION
FUSION
98328640 not registered Live/Pending
MagScope, LLC
2023-12-22

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