Surge Cardiovascular 213-010
GUDID 00817278010033
Suture Guide, Single Pack
Alliant Enterprises, LLC
Operative-site suture holder| Primary Device ID | 00817278010033 |
| NIH Device Record Key | d1cb743e-f51c-498f-8aa1-befe39b758cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surge Cardiovascular |
| Version Model Number | 213-010 |
| Catalog Number | 213-010 |
| Company DUNS | 121170653 |
| Company Name | Alliant Enterprises, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817278010033 [Primary] |
FDA Product Code
| GEJ | Carrier, Ligature |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
[00817278010033]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-06-23 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [Surge Cardiovascular]
| 10817278012676 | Rigid cardiac sucker, fluted tip, 1/4" connector, 13" length, non-sterile |
| 00817278012662 | Suction Safety Device, Non-Sterile |
| 10817278012492 | Cardiac Sucker, flexible, fluted tip, 1/4" connector, 14.5" length, non-sterile |
| 00817278012464 | Adult Tourniquet Kit with Snare, 1 red, 1 blue, 7" length, non-sterile |
| 00817278012389 | ALPINE Femoral Venous Cannula, 28 Fr |
| 00817278012372 | ALPINE Femoral Venous Cannula, 26 Fr |
| 00817278012365 | ALPINE Femoral Venous Cannula, 24 Fr |
| 00817278012358 | ALPINE Femoral Venous Cannula, 22 Fr |
| 00817278012341 | ALPINE Femoral Venous Cannula, 20 Fr |
| 10817278012232 | PEAK Left Ventricular Vent Cannula, 20 Fr |
| 10817278012225 | PEAK Left Ventricular Vent Cannula, 18 Fr |
| 10817278012218 | PEAK Left Ventricular Vent Cannula, 16 Fr |
| 20817278011539 | Retrograde Cardioplegia Cannula, Self Inflating Balloon (18mm) and Guidewire Stylet, 12.5" Lengt |
| 10817278011983 | Vein graft cannula, blunt tip, free-flow (2 pack) |
| 10817278011976 | Vein Graft Cannula-Blunt Tip w/Luer Extension |
| 10817278011907 | Retrograde Cardioplegia Cannula, Self Inflating Textured Balloon (18mm) & Guidewire Stylet 15Fr |
| 10817278011891 | Retrograde Cardioplegia Cannula, Manually Inflating Balloon & Rigid Stylet w/stopcock, 15Fr |
| 20817278011751 | Cardiac Sucker, flexible, fluted tip, 1/4" connector, 14.5" length, non-sterile |
| 20817278011744 | Perfusion Set, Recirculating |
| 20817278011737 | Antegrade/Retrograde Perfusion Set w/self-adhesive high flow stopcock base, Non-sterile |
| 10817278011716 | Adult Tourniquet Kit w/Snare, Custom Kit, Non-Sterile |
| 30817278011697 | Sarns Sternal Saw II Blades, Non-Sterile |
| 10817278011679 | Perfusion Set, coronary perfusion, Y-type, 13.5" length with colored clamps |
| 10817278011631 | Adult Tourniquet Kit with Snare, Custom Kit, 6 Tubes |
| 10817278011624 | Retrograde Cardioplegia Cannula, Self Inflate Smooth Balloon Rigid Stylet, SureTouch, 12.5", 15F |
| 10817278011617 | Retrograde Cardioplegia Cannula, Self Inflating Balloon (18mm) Textured Balloon and Rigid Stylet |
| 10817278011600 | Retrograde Cardioplegia Cannula, Self Inflate Smooth Balloon Rigid Stylet, SureTouch, 10.5", 15F |
| 10817278011594 | Retrograde Cardioplegia Cannula, Manually Inflating Smooth Balloon, Stopcock, Guidewire, 15Fr |
| 10817278011563 | Retrograde Cardioplegia Cannula, Manual Inflate Smooth Balloon Stopcock Rigid Stylet SureTouch 1 |
| 10817278011556 | Retrograde Cardioplegia Cannula, Self-Inflating text med balloon, Sure Touch Handle, 12.5" lengt |
| 10817278011549 | Retrograde Cardioplegia Cannula, Self-Inflating Smooth balloon, Rigid stylet, 12.5" length, 15Fr |
| 10817278011532 | Retrograde Cardioplegia Cannula, Self Inflating Balloon (18mm) and Guidewire Stylet |
| 10817278011501 | Retrograde Cardioplegia Cannula, Manual Inflate, Stopcock Rigid Stylet, SureTouch Handle 15Fr |
| 10817278011402 | Myocardial temperature probe, 18mm needle |
| 10817278011365 | Retrograde Cardioplegia Cannula, Self Inflating Balloon (18mm) and Rigid Stylet |
| 20817278011355 | Coronary Artery Retraction Clip, 3.0mm, Non-Sterile |
| 20817278011300 | Adult Tourniquet Kit with Snare, 1 red, 1 blue, 7" length, non-sterile |
| 20817278011294 | Pediatric Tourniquet Kit with Snare, 1 red, 2 blue, 3 clear, 5.5" length, non-sterile |
| 10817278011280 | Mini rigid cardiac sucker, soft tip w/ side ports, 1/4" connector, 9" length, non-sterile |
| 10817278011273 | Rigid cardiac sucker, fluted tip, 1/4" connector, 13" length, non-sterile |
| 10817278011266 | Suction Safety Device, Non-Sterile |
| 10817278011181 | Vessel Cannula, Guyton soft tip IMA needle, 1.5mm tip, Non-Sterile |
| 10817278011174 | Internal Coronary Vessel Cannula, stainless steel, 1mm bulb tip, Non-Sterile |
| 10817278011167 | Vessel Cannula, rigid, 3mm beveled tip, Non-Sterile |
| 10817278011143 | Saphenous Vein Cannula, Opaque, Non-Sterile, 1000pk |
| 00817278011139 | Saphenous Vein Cannula, opaque, 3mm blunt tip, Non-Sterile |
| 00817278011122 | Perfusion Cannula, free-flow, 3mm blunt tip, Non-Sterile |
| 00817278011115 | Perfusion Cannula, one-way, 3mm blunt tip, Non-Sterile |
| 10817278011105 | Multiple Perfusion Set with Vent Line, 15" length, color-coded clamps, Non Sterile |
| 10817278011099 | Multiple 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 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.