Surge Cardiovascular SUT-013

GUDID 10817278010016

Curved Suture Guide, 3-Pack

Alliant Enterprises, LLC

Operative-site suture holder
Primary Device ID10817278010016
NIH Device Record Keya874e80d-4c9b-4031-91a2-3a885b8ba055
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurge Cardiovascular
Version Model NumberSUT-013
Catalog NumberSUT-013
Company DUNS121170653
Company NameAlliant Enterprises, LLC
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817278010019 [Primary]
GS110817278010016 [Package]
Contains: 00817278010019
Package: Case [4 Units]
In Commercial Distribution

FDA Product Code

GEJCarrier, Ligature

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


[10817278010016]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-06-23
Device Publish Date2016-09-23

On-Brand Devices [Surge Cardiovascular]

10817278012676Rigid cardiac sucker, fluted tip, 1/4" connector, 13" length, non-sterile
00817278012662Suction Safety Device, Non-Sterile
10817278012492Cardiac Sucker, flexible, fluted tip, 1/4" connector, 14.5" length, non-sterile
00817278012464Adult Tourniquet Kit with Snare, 1 red, 1 blue, 7" length, non-sterile
00817278012389ALPINE Femoral Venous Cannula, 28 Fr
00817278012372ALPINE Femoral Venous Cannula, 26 Fr
00817278012365ALPINE Femoral Venous Cannula, 24 Fr
00817278012358ALPINE Femoral Venous Cannula, 22 Fr
00817278012341ALPINE Femoral Venous Cannula, 20 Fr
10817278012232PEAK Left Ventricular Vent Cannula, 20 Fr
10817278012225PEAK Left Ventricular Vent Cannula, 18 Fr
10817278012218PEAK Left Ventricular Vent Cannula, 16 Fr
20817278011539Retrograde Cardioplegia Cannula, Self Inflating Balloon (18mm) and Guidewire Stylet, 12.5" Lengt
10817278011983Vein graft cannula, blunt tip, free-flow (2 pack)
10817278011976Vein Graft Cannula-Blunt Tip w/Luer Extension
10817278011907Retrograde Cardioplegia Cannula, Self Inflating Textured Balloon (18mm) & Guidewire Stylet 15Fr
10817278011891Retrograde Cardioplegia Cannula, Manually Inflating Balloon & Rigid Stylet w/stopcock, 15Fr
20817278011751Cardiac Sucker, flexible, fluted tip, 1/4" connector, 14.5" length, non-sterile
20817278011744Perfusion Set, Recirculating
20817278011737Antegrade/Retrograde Perfusion Set w/self-adhesive high flow stopcock base, Non-sterile
10817278011716Adult Tourniquet Kit w/Snare, Custom Kit, Non-Sterile
30817278011697Sarns Sternal Saw II Blades, Non-Sterile
10817278011679Perfusion Set, coronary perfusion, Y-type, 13.5" length with colored clamps
10817278011631Adult Tourniquet Kit with Snare, Custom Kit, 6 Tubes
10817278011624Retrograde Cardioplegia Cannula, Self Inflate Smooth Balloon Rigid Stylet, SureTouch, 12.5", 15F
10817278011617Retrograde Cardioplegia Cannula, Self Inflating Balloon (18mm) Textured Balloon and Rigid Stylet
10817278011600Retrograde Cardioplegia Cannula, Self Inflate Smooth Balloon Rigid Stylet, SureTouch, 10.5", 15F
10817278011594Retrograde Cardioplegia Cannula, Manually Inflating Smooth Balloon, Stopcock, Guidewire, 15Fr
10817278011563Retrograde Cardioplegia Cannula, Manual Inflate Smooth Balloon Stopcock Rigid Stylet SureTouch 1
10817278011556Retrograde Cardioplegia Cannula, Self-Inflating text med balloon, Sure Touch Handle, 12.5" lengt
10817278011549Retrograde Cardioplegia Cannula, Self-Inflating Smooth balloon, Rigid stylet, 12.5" length, 15Fr
10817278011532Retrograde Cardioplegia Cannula, Self Inflating Balloon (18mm) and Guidewire Stylet
10817278011501Retrograde Cardioplegia Cannula, Manual Inflate, Stopcock Rigid Stylet, SureTouch Handle 15Fr
10817278011402Myocardial temperature probe, 18mm needle
10817278011365Retrograde Cardioplegia Cannula, Self Inflating Balloon (18mm) and Rigid Stylet
20817278011355Coronary Artery Retraction Clip, 3.0mm, Non-Sterile
20817278011300Adult Tourniquet Kit with Snare, 1 red, 1 blue, 7" length, non-sterile
20817278011294Pediatric Tourniquet Kit with Snare, 1 red, 2 blue, 3 clear, 5.5" length, non-sterile
10817278011280Mini rigid cardiac sucker, soft tip w/ side ports, 1/4" connector, 9" length, non-sterile
10817278011273Rigid cardiac sucker, fluted tip, 1/4" connector, 13" length, non-sterile
10817278011266Suction Safety Device, Non-Sterile
10817278011181Vessel Cannula, Guyton soft tip IMA needle, 1.5mm tip, Non-Sterile
10817278011174Internal Coronary Vessel Cannula, stainless steel, 1mm bulb tip, Non-Sterile
10817278011167Vessel Cannula, rigid, 3mm beveled tip, Non-Sterile
10817278011143Saphenous Vein Cannula, Opaque, Non-Sterile, 1000pk
00817278011139Saphenous Vein Cannula, opaque, 3mm blunt tip, Non-Sterile
00817278011122Perfusion Cannula, free-flow, 3mm blunt tip, Non-Sterile
00817278011115Perfusion Cannula, one-way, 3mm blunt tip, Non-Sterile
10817278011105Multiple Perfusion Set with Vent Line, 15" length, color-coded clamps, Non Sterile
10817278011099Multiple Perfusion Set, 15" length, one 3" arm, three 10" arms color clamps, Non Sterile

Trademark Results [Surge Cardiovascular]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURGE CARDIOVASCULAR
SURGE CARDIOVASCULAR
85323915 4119679 Live/Registered
Alliant Surgical Products, LLC
2011-05-18

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