FDA.reportPublic FDA data

STRADIS

Primary DI
M752525028R11
Brand
STRADIS
Company
STRADIS MEDICAL, LLC
Model
525-028
Device description
4FR.MICRO INTRODUCER KIT
Published
2016-09-17
Public version status
Update
Distribution status
Not 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
M752525028R11PrimaryHIBCC0

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 Gauge0
Length0

Regulatory Flags#

DUNS number
174262477
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7525250271STRADIS525-027525-0272016-05-04
M7525250291STRADIS525-029525-0292016-05-04
M752525021R11STRADIS525-0212016-09-10
M752525027R11STRADIS525-0272016-09-10
M752525029R11STRADIS525-0292016-09-17
M752525037R11STRADIS525-0372016-09-17
M752525038R10Stradis Medical, LLC.525-038 R12017-04-12
M752525038R11STRADIS525-0382016-09-10
M752525038SAR11STRADIS525-038SA2016-09-10
M752525065R11STRADIS525-0652016-09-10
M752525072R11STRADIS525-0722016-09-10
M7525250791STRADIS525-079525-0792016-05-04
M752525079R11STRADIS525-0792016-09-10
M752525083R11STRADIS525-0832016-09-10
M7525251551STRADIS525-1552016-09-17
M752525202R11STRADIS525-2022016-09-10
M752525462R11STRADIS525-4622016-09-10
M7525251811STRADIS525-1812017-04-01
M75257032650STRADIS HEALTHCARE570-32652023-01-17
M752682026NLXXXXX9STRADIS682-026NL2025-12-31

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
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
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