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Typenex Introducer Set

FDA UDI

Class II (US FDA UDI)

by Typenex Medical, LLC

Identity

Trade Name
Typenex Introducer Set FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
5 Fr x 10 cm COAX MICRO INTRODUCER, Micro access tip .18 Ni GW with AU tip NON-MARKED, echo needle FDA UDI
Model / Reference
MS0636 FDA UDI
Description
5 Fr x 10 cm COAX MICRO INTRODUCER, Micro access tip .18 Ni GW with AU tip NON-MARKED, echo needle FDA UDI

Identifiers

Primary DI / UDI-DI
00812269033039 FDA UDI
FDA Product Code
OFL FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 10 Centimeter FDA UDI
Outer Diameter — 1.67 Millimeter FDA UDI

Category: Vascular catheter introduction set, nonimplantable

Typenex Introducer Set by Typenex Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Typenex Medical, LLC

Sources (1)

  • FDA UDI c6a31274-1e1f-4008-940b-b16d8727a5d4 35 fields · synced Jun 8, 2026