| Primary Device ID | D79630131 | 
| NIH Device Record Key | feb02b72-844b-43a2-a477-e7ec81e93c25 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | MARK3 | 
| Version Model Number | 3013 | 
| Company DUNS | 096191093 | 
| Company Name | CARGUS INTERNATIONAL, INC | 
| Device Count | 4 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 72 Degrees Fahrenheit | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | D79630130 [Unit of Use] | 
| HIBCC | D79630131 [Primary] | 
| HIBCC | D79630132 [Package] Package: Box [4 Units] In Commercial Distribution | 
| ELW | Material, Impression | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-10-05 | 
| D79690921 | Etchant Gel 37% Jumbo Kit 50ml. Syringe(1x50ml. Syr., 4x1.2ml. Empty Syr. & 50 Tips) - MARK3 | 
| D79690911 | Etchant Gel 37% Bulk Pack 25/bx. (25x1.2ml. Syr. & 50 Tips) - MARK3 | 
| D79690901 | Etchant Gel 37% 4/bx. (4x1.2ml Syr. & 20 Tips) - MARK3 | 
| D79690101 | Alginate Substitute Fast Set 50ml. Cartridges 8/pk. - MARK3 | 
| D7967799CASE1 | Digital Xray Sensor Sleeves #2 1-5/8"x8" 500pcs/bx - 36bxs/cs - MARK3 | 
| D79677991 | Digital Xray Sensor Sleeves #2 1-5/8"x8" 500/bx. - MARK3 | 
| D7967798CASE1 | Digital Xray Sensor Sleeves #1 1-3/8"x8" 500pcs/bx - 36bxs/cs - MARK3 | 
| D79677981 | Digital Xray Sensor Sleeves #1 1-3/8"x8" 500/bx. - MARK3 | 
| D796710200 | 5% Sodium Fluoride Varnish with TCP Caramel Unidose 50/bx. - MARK3 | 
| D79671011 | 5% Sodium Fluoride Varnish with TCP Spearmint Unidose 50/bx. - MARK3 | 
| D79671001 | 5% Sodium Fluoride Varnish with TCP Bubble Gum Unidose 50/bx. - MARK3 | 
| D79648891 | Hybrid Composite C2 Unidose .25gm. 20/pk. - MARK3 | 
| D79648881 | Hybrid Composite B3 Unidose .25gm. 20/pk. - MARK3 | 
| D79648871 | Hybrid Composite B2 Unidose .25gm. 20/pk. - MARK3 | 
| D79648861 | Hybrid Composite B1 Unidose .25gm. 20/pk. - MARK3 | 
| D79648851 | Hybrid Composite A4 Unidose .25gm. 20/pk. - MARK3 | 
| D79648841 | Hybrid Composite A3.5 Unidose .25gm. 20/pk. - MARK3 | 
| D79648831 | Hybrid Composite A3 Unidose .25gm. 20/pk. - MARK3 | 
| D79648811 | Hybrid Composite A1 Unidose .25gm. 20/pk. - MARK3 | 
| D79641031 | Temporary 10:1 Crown & Bridge A3 75gm. Cartridge & 10 Tips - MARK3 | 
| D79641021 | Temporary 10:1 Crown & Bridge A2 75gm. Cartridge & 10 Tips - MARK3 | 
| D79641011 | Temporary 10:1 Crown & Bridge A1 75gm. Cartridge & 10 Tips - MARK3 | 
| D79641010 | Temporary 10:1 Crown & Bridge A1 75gm. Cartridge & 10 Tips | 
| D79630261 | VPS 380 Impression Material Monophase Regular Set 2/pk. - MARK3 | 
| D79630251 | VPS 380 Impression Material Heavy Body Regular Set 2/pk. - MARK3 | 
| D7963017BULK1 | VPS Impression Material Monophase Fast Set 50ml. Cartridges 100/cs. - MARK3 | 
| D79630171 | VPS Impression Material Monophase Fast Set 50ml. Cartridges 4/bx. - MARK3 | 
| D7963016BULK1 | VPS Impression Material Monophase Regular Set 50ml. Cartridges 100/cs. - MARK3 | 
| D79630161 | VPS Impression Material Monophase Regular Set 50ml. Cartridges 4/bx. - MARK3 | 
| D7963015BULK1 | VPS Impression Material Heavy Fast Set 50ml. Cartridges 100/cs. - MARK3 | 
| D79630151 | VPS Impression Material Heavy Fast Set 50ml. Cartridges 4/bx. - MARK3 | 
| D7963014BULK1 | VPS Impression Material Heavy Regular Set 50ml. Cartridges 100/cs. - MARK3 | 
| D79630141 | VPS Impression Material Heavy Regular Set 50ml. Cartridges 4/bx. - MARK3 | 
| D7963013BULK1 | VPS Impression Material Medium Fast Set 50ml. Cartridges 100/cs. - MARK3 | 
| D79630131 | VPS Impression Material Medium Fast Set 50ml. Cartridges 4/bx. - MARK3 | 
| D7963012BULK1 | VPS Impression Material Medium Regular 50ml. Cartridges Set 100/cs. - MARK3 | 
| D79630121 | VPS Impression Material Medium Regular 50ml. Cartridges Set 4/bx. - MARK3 | 
| D7963011BULK1 | VPS Impression Material Light Fast Set 50ml. Cartridges 100/cs. - MARK3 | 
| D79630111 | VPS Impression Material Light Fast Set 50ml. Cartridges 4/bx. - MARK3 | 
| D7963010BULK1 | VPS Impression Material Light Regular Set 50ml. Cartridges 100/cs. - MARK3 | 
| D79630101 | VPS Impression Material Light Regular Set 50ml. Cartridges 4/bx. - MARK3 | 
| D79630051 | VPS Putty Fast Set 300ml. each Base & Catalyst - MARK3 | 
| D79630041 | VPS Putty Regular Set 300ml. each Base & Catalyst - MARK3 | 
| D79630001 | VPS Tray Adhesive 10ml. - MARK3 | 
| D7962127CASE1 | T Style Handle Sleeves 4" x 5-3/4" 500pcs/bx - 60bxs/cs - MARK3 | 
| D79621271 | T Style Handle Sleeves 4" x 5-3/4" 500/bx. - MARK3 | 
| D7962125CASE1 | Full Chair Sleeves 29" x 80" 125pcs/bx - 3bxs/cs - MARK3 | 
| D79621251 | Full Chair Sleeves 29" x 80" 125/bx. - MARK3 | 
| D7962124CASE1 | Half Chair Covers 27-1/2" x 24" 225pcs/bx - 3bxs/cs - MARK3 | 
| D79621241 | Half Chair Covers 27-1/2" x 24" 225/bx. - MARK3 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  MARK3  86424211  4747849 Live/Registered | KWIKBOOST, LLC 2014-10-15 | 
|  MARK3  86138657  4579520 Live/Registered | Cargus International Inc. 2013-12-09 |