FDA.reportPublic FDA data

Typenex Introducer Set

Primary DI
10810050855805
Brand
Typenex Introducer Set
Company
TYPENEX MEDICAL LLC
Model
MS2335S
Device description
Micro Introducer: 4F x 20cm, Smooth Tip Needle, 0.018 Nitinol/AU Wire, Stiffen Dilator
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFLPercutaneous Sheath Introducer Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFLPercutaneous Sheath Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810050855805PackageGS110In Commercial Distribution
20810050855802PackageGS110In Commercial Distribution
00810050855808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005085580510810050855805
2081005085580220810050855802
00810050855808008100508558088100508558080810050855808

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Inner Diameter1.333Millimeter
Catheter Length20Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600850213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810050855850Microscope SlidesPS0404G2026-05-14
10810050855867Microscope SlidesPS0404L2026-05-14
10810050855874Microscope SlidesPS0404N2026-05-14
10810050855881Microscope SlidesPS0404P2026-05-14
10810050855898Microscope SlidesPS0404Y2026-05-14
10810050855904Embedding CassetteEC0616YXT-LASER2026-05-14
10810050855911Embedding CassetteEC0616PXT-LASER2026-05-14
10810050855928Embedding CassetteEC0616WXT-LASER2026-05-14
10810050855935Embedding CassetteEC0616EXT-LASER2026-05-14
10810050855843Rad ControlRT0301XBA2026-05-06
10810050855836Microscope SlidesLC0105B2026-03-23
20810050855833Microscope SlidesLC0105B2026-03-23
B050SL1000020Sterile LabelsSL-1000022026-03-17
B050SL1000021Sterile LabelsSL-1000022026-03-17
00810050851923Specimen Collection SwabSW0202SW02022020-06-01
00810050851909Specimen Collection SwabSW0102SW01022020-06-01
00810050852388Anterior Nasal SwabSW0302SW03022020-08-20
00810050855815ThermoFlo®60612026-01-26
00810050855808Typenex Introducer SetMS2335S2025-11-17
00810050854436Typenex Heat and Moisture Exchanger with FilterRE01012022-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050855808Typenex Introducer SetTYPENEX MEDICAL LLCOFL2025-11-17
H965459000Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459010Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459020Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459150Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459160Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459170Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459180Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
10197106004050CARDINAL HEALTHCardinal Health 200, LLCOFL2022-10-27
00810050853774Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853804Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853811Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853842Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853460Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-01-26
00810050853491Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-01-26
00810050853514Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-01-26
00810050851954Typenex Introducer SetTYPENEX MEDICAL LLCOFL2020-06-09
00812269033763Typenex Introducer SetTYPENEX MEDICAL LLCOFL2020-02-24
00812269033800Typenex Introducer SetTYPENEX MEDICAL LLCOFL2020-02-24
00812269032957Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269032971Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269032995Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033015Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033039Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033053Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033077Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033091Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033114Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033138Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033152Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18