Typenex Introducer Set

GUDID 10810050855805

Micro Introducer: 4F x 20cm, Smooth Tip Needle, 0.018 Nitinol/AU Wire, Stiffen Dilator

TYPENEX MEDICAL LLC

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10810050855805
• NIH Device Record Key: 64a42f5a-1fa2-4f98-8edc-b7a85205c7e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Typenex Introducer Set
• Version Model Number: MS2335S
• 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

Device Dimensions

• Catheter Length: 20 Centimeter
• Catheter Inner Diameter: 1.333 Millimeter
• Catheter Length: 20 Centimeter
• Catheter Inner Diameter: 1.333 Millimeter
• Catheter Length: 20 Centimeter
• Catheter Inner Diameter: 1.333 Millimeter
• Catheter Length: 20 Centimeter
• Catheter Inner Diameter: 1.333 Millimeter
• Catheter Length: 20 Centimeter
• Catheter Inner Diameter: 1.333 Millimeter
• Catheter Length: 20 Centimeter
• Catheter Inner Diameter: 1.333 Millimeter
• Catheter Length: 20 Centimeter
• Catheter Inner Diameter: 1.333 Millimeter
• Catheter Length: 20 Centimeter
• Catheter Inner Diameter: 1.333 Millimeter
• Catheter Length: 20 Centimeter
• Catheter Inner Diameter: 1.333 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050855808 [Primary]
GS1	10810050855805 [Package]; Contains: 00810050855808; Package: Case [10 Units]; In Commercial Distribution
GS1	20810050855802 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Product Code

• OFL: Percutaneous Sheath Introducer Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-25
• Device Publish Date: 2025-11-17

On-Brand Devices [Typenex Introducer Set]

• 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
• 10810050855805: Micro Introducer: 4F x 20cm, Smooth Tip Needle, 0.018 Nitinol/AU Wire, Stiffen Dilator