FDA.reportPublic FDA data

Percutaneous Micro Introducer Kit

Primary DI
00886333215089
Brand
Percutaneous Micro Introducer Kit
Company
ARGON MEDICAL DEVICES, INC.
Model
497819
Catalog number
497819
Device description
Percutaneous Micro Introducer Kit 5F
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10886333215086PackageGS110Not in Commercial Distribution
20886333215083PackageGS150Not in Commercial Distribution
00886333215089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088633321508610886333215086
2088633321508320886333215083
00886333215089008863332150898863332150890886333215089

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
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333210893Guidewire3951263951262016-09-21
00886333001408Skin Fix8025000008025000002022-07-14
00886333217618Skater™ Fix8025000018025000012022-07-14
00886333226320Co-Axial Introducer NeedleMCXS1620BXMCXS1620BX2022-07-21
00886333000005SKATER™ Drainage Catheter751106025E7511060252022-07-11
00886333000012SKATER™ Drainage Catheter751106035E7511060352022-07-12
00886333000029SKATER™ Drainage Catheter751107025E7511070252022-07-12
00886333000036SKATER™ Drainage Catheter751107035E7511070352022-07-11
00886333000043SKATER™ Drainage Catheter751108025E7511080252022-07-11
00886333000067SKATER™ Drainage Catheter751110025E7511100252022-07-12
00886333000074SKATER™ Drainage Catheter751110035E7511100352022-07-12
00886333000081SKATER™ Drainage Catheter751112025E7511120252022-07-13
00886333000098SKATER™ Drainage Catheter751112035E7511120352022-07-12
00886333000104SKATER™ Drainage Catheter751114025E7511140252022-07-12
00886333000111SKATER™ Drainage Catheter755106025E7551060252022-07-13
00886333000128SKATER™ Drainage Catheter755106035E7551060352022-07-12
00886333000135SKATER™ Drainage Catheter755107025E7551070252022-07-13
00886333000142SKATER™ Drainage Catheter755107035E7551070352022-07-12
00886333000159SKATER™ Drainage Catheter755108025E7551080252022-07-12
00886333000166SKATER™ Drainage Catheter 755108035E7551080352022-07-13

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