| Primary Device ID | 00810050851961 | 
| NIH Device Record Key | 5242ceb1-9169-4c15-9bab-56324a51300c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Typenex Introducer Set | 
| Version Model Number | MS1712 | 
| Company DUNS | 600850213 | 
| Company Name | TYPENEX MEDICAL 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 | true | 
| 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 | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | |
| Phone | 312-888-4064 | 
| mchoquette@typenex.com | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Catheter Length | 12 Centimeter | 
| Outer Diameter | 2.33 Millimeter | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00810050851954 [Primary] | 
| GS1 | 00810050851961 [Package] Contains: 00810050851954 Package: [10 Units] In Commercial Distribution | 
| OFL | Percutaneous Sheath Introducer Kit | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-06-17 | 
| Device Publish Date | 2020-06-09 | 
| 00812269033169 | 4 Fr x 40cm COAX MICRO INTRODUCER, Micro Access tip .18 Ni GW with AU tip, NON-MARKED, STIFF Di | 
| 00812269033145 | 4 Fr x 30cm COAX MICRO INTRODUCER, Micro Access tip .18 Ni GW with AU tip, NON-MARKED, STIFF Di | 
| 00812269033121 | 4 Fr x 15cm COAX MICRO INTRODUCER, Micro Access tip .18 Ni GW with AU tip, NON-MARKED, STIFF Di | 
| 00812269033107 | 4 Fr x 45 cm HV MICRO INTRODUCER, micro access tip .18, Ni GW, AU tip MARKED | 
| 00812269033084 | 4 Fr x 24 cm HV MICRO INTRODUCER, micro access tip .18, Ni GW, AU tip MARKED | 
| 00812269033060 | 4 Fr x 12 cm HV MICRO INTRODUCER, micro access tip .18, Ni GW, AU tip MARKED | 
| 00812269033046 | 5 Fr x 10 cm COAX MICRO INTRODUCER, Micro access tip .18 Ni GW with AU tip NON-MARKED, echo nee | 
| 00812269033022 | 4 Fr x 70 cm Elite HV MICRO INTRODUCER, Micro Access Tip ./18 Ni GW with AU tip, NON-MARKED, ech | 
| 00812269033008 | 4 Fr x 45 cm Elite HV MICRO INTRODUCER, Micro Access Tip ./18 Ni GW with AU tip, NON-MARKED, ec | 
| 00812269032988 | 4 Fr x 24 cm Elite HV MICRO INTRODUCER, Micro Access Tip ./18 Ni GW with AU tip, NON-MARKED, ech | 
| 00812269032964 | 4 Fr x 12 cm Elite HV MICRO INTRODUCER, Micro Access Tip ./18 Ni GW with AU tip, NON-MARKED, ech | 
| 00812269033824 | 6.5 Fr x 12 cm HV MICRO INTRODUCER, Micro Access Tip .018 Ni GW, NON-MARKED, echo needle | 
| 00812269033770 | 6 Fr x 12 cm HV MICRO INTRODUCER, Micro Access Tip .018 Ni GW, NON-MARKED, echo needle | 
| 00810050851961 | 7 Fr x 12 cm HV MICRO INTRODUCER, Micro Access Tip .018 Ni GW, NON-MARKED, echo needle | 
| 00810050853538 | 4F X 10 CM COAX MICRO INTRODUCER, NON-MARKED | 
| 00810050853521 | 4F X 60 CM COAX INTRODUCER, NON-MARKED, -Stiffen | 
| 00810050853507 | 4F X 40 CM COAX INTRODUCER, NON-MARKED, -Stiffen | 
| 00810050853477 | 4F X 30 CM COAX INTRODUCER, NON-MARKED, -Stiffen | 
| 00810050853859 | 7F x 7cm Venous Coaxial Introducer, tipped for .018 Micro Access, .018 x 40cm NiTi/AU Mandrel Gu | 
| 00810050853828 | 6F x 7cm Venous Coaxial Introducer, tipped for .018 Micro Access, .018 x 40cm NiTi/AU Mandrel Gu | 
| 10810050853801 | 7F x 10cm Venous Coaxial Introducer, tipped for .018 Micro Access, .018 x 40cm NiTi/AU Mandrel G | 
| 00810050853781 | 6F x 10cm Venous Coaxial Introducer, tipped for .018 Micro Access, .018 x 40cm NiTi/AU Mandrel G |