FDA.reportPublic FDA data

Typenex Introducer Set

Primary DI
00810050853804
Brand
Typenex Introducer Set
Company
TYPENEX MEDICAL LLC
Model
MS2112
Device description
7F x 10cm Venous Coaxial Introducer, tipped for .018 Micro Access, .018 x 40cm NiTi/AU Mandrel Guidewire 7.0 coil with St. Tip, 21Ga x 7cm Introducer Needle - Echogenic
Published
2021-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
10810050853801PackageGS110In Commercial Distribution
00810050853804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005085380110810050853801
00810050853804008100508538048100508538040810050853804

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/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Inner Diameter0
Catheter Length0

Contacts#

Phone, Email table
PhoneEmail
312-888-4064mchoquette@typenex.com

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
00810050851954Typenex Introducer SetMS17122020-06-09
00810050853460Typenex Introducer SetMS1235S2021-01-26
00810050853491Typenex Introducer SetMS1335S2021-01-26
00810050853514Typenex Introducer SetMS1835S2021-01-26
00810050853774Typenex Introducer SetMS19122021-08-11
00810050853811Typenex Introducer SetMS20122021-08-11
00810050853842Typenex Introducer SetMS22122021-08-11
00810050855808Typenex Introducer SetMS2335S2025-11-17
00812269032957Typenex Introducer SetMS02362019-09-18
00812269032971Typenex Introducer SetMS03362019-09-18
00812269032995Typenex Introducer SetMS04362019-09-18
00812269033015Typenex Introducer SetMS05362019-09-18
00812269033039Typenex Introducer SetMS06362019-09-18
00812269033053Typenex Introducer SetMS02442019-09-18
00812269033077Typenex Introducer SetMS03442019-09-18
00812269033091Typenex Introducer SetMS04442019-09-18
00812269033114Typenex Introducer SetMS1144S2019-09-18
00812269033138Typenex Introducer SetMS1244S2019-09-18
00812269033152Typenex Introducer SetMS1344S2019-09-18
00812269033763Typenex Introducer SetMS15122020-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050855808Typenex Introducer SetTYPENEX MEDICAL LLCOFL2025-11-17
00810050853774Typenex 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
00810050853538Typenex 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 SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269032971Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269032995Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033015Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033039Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033053Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033077Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033091Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033114Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033138Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033152Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00841268105744Micro-Introducer Kit with Side-HolesGALT MEDICAL CORP.OFL2018-02-07
00841268105751Micro-Introducer Kit with Side-HolesGALT MEDICAL CORP.OFL2018-02-07
00841268100015Tearaway Introducer KitGALT MEDICAL CORP.OFL2018-02-06
00841268100022Tearaway Introducer KitGALT MEDICAL CORP.OFL2018-02-06
00841268100039Tearaway Introducer KitGALT MEDICAL CORP.OFL2018-02-06
00841268100046Tearaway Introducer KitGALT MEDICAL CORP.OFL2018-02-06
00841268100053Tearaway Introducer KitGALT MEDICAL CORP.OFL2018-02-06
00841268100060Tearaway Introducer KitGALT MEDICAL CORP.OFL2018-02-06