| Primary Device ID | 00812269033107 |
| NIH Device Record Key | e65fe331-3a58-4215-891e-61b01099db34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Typenex Introducer Set |
| Version Model Number | MS0444 |
| 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 | false |
| 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 |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Length | 45 Centimeter |
| Outer Diameter | 1.33 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812269033091 [Primary] |
| GS1 | 00812269033107 [Package] Contains: 00812269033091 Package: carton [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 | 2019-09-26 |
| Device Publish Date | 2019-09-18 |
| 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 |