FDA.reportPublic FDA data

Navilyst Medical

Primary DI
H965459180
Brand
Navilyst Medical
Company
Angiodynamics, Inc.
Model
45-918
Device description
MiniStick II Microintroducer Kit 3F, Peelable Sheath/Dilator, 45cm Nitinol/SS Guidewire
Published
2024-10-21
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
H965459181PackageHIBCC5In Commercial Distribution
H965459180PrimaryHIBCC0

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
Catheter Length0
Guidewire Diameter0
Guidewire Length0
Needle Gauge0

Contacts#

Phone, Email table
PhoneEmail
+1(800)772-6446customerservice@angiodynamics.com

Regulatory Flags#

DUNS number
079252781
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
H787065068010Micro Access065068012016-09-20
H787065068020Micro Access065068022016-09-20
H787065068030Micro Access065068032016-09-20
H787065068040Micro Access065068042016-09-20
H787065068050Micro Access065068052016-09-20
H787065072010Micro Access065072012016-09-20
H787065072020Micro Access065072022016-09-20
H787065072030Micro Access065072032016-09-20
H787065072040Micro Access065072042016-09-20
H787065072100Morpheus065072102016-09-20
H787065072110Morpheus065072112016-09-20
H787065072120Morpheus065072122016-09-20
H787065072130Morpheus065072132016-09-20
H787065076010Embosafe065076012016-09-20
H787065076020Embosafe065076022016-09-20
H787065076030Embosafe065076032016-09-20
H787065084020Morpheus065084022016-09-20
H787065084030Morpheus065084032016-09-20
H787065084040Morpheus065084042016-09-20
H787065086010Micro Access065086012016-09-20

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