Nit-Vu

GUDID H787058001195

High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD

ANGIODYNAMICS, INC.

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual
Primary Device IDH787058001195
NIH Device Record Keyd495d709-15b8-48fa-8237-4d8d48ab00a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNit-Vu
Version Model Number05800119
Company DUNS079105071
Company NameANGIODYNAMICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com

Device Dimensions

Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter
Outer Diameter0.014 Inch
Length80 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115051684024563 [Secondary]
HIBCCH787058001190 [Primary]
HIBCCH787058001195 [Package]
Contains: H787058001190
Package: BOX [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

On-Brand Devices [Nit-Vu]

H787058001315High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001305High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 2 CM COIL, STIFF
H787058001295High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001285High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 2 CM COIL, STIFF
H787058001275High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 2 CM COIL, STIFF
H787058001265High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001255High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 2 CM COIL, STIFF
H787058001245High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 2 CM COIL, STIFF
H787058001235High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001225High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 2 CM COIL, STIFF
H787058001215High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001205High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 2 CM COIL, STIFF
H787058001195High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001175High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 2 CM COIL, STIFF
H787058001165High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001155High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001145High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001135High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001125High Perfomanace Micro Guidewire, NITINOL, ANGLED, 7 CM, Coil INTERMEDIATE
H787058001115High Perfomanace Micro Guidewire, NITINOL, ANGLED, 7 CM, Coil INTERMEDIATE
H787058001105High Perfomanace Micro Guidewire, NITINOL, ANGLED, 7 CM, Coil INTERMEDIATE
H787058001095High Perfomanace Micro Guidewire, NITINOL, ANGLED, 7 CM, Coil INTERMEDIATE
H787058001085High Perfomanace Micro Guidewire, NITINOL, ANGLED, 7 CM, Coil INTERMEDIATE
H787058001075High Perfomanace Micro Guidewire, NITINOL, ANGLED, 7 CM, Coil INTERMEDIATE
H787058001065High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001055High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001045High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 5 CM, Coil STANDARD
H787058001035High Perfomanace Micro Guidewire, NITINOL, ANGLED, 7 CM, Coil INTERMEDIATE
H787058001025High Perfomanace Micro Guidewire, NITINOL, ANGLED, 7 CM, Coil INTERMEDIATE
H787058001015High Perfomanace Micro Guidewire, NITINOL, ANGLED, 7 CM, Coil INTERMEDIATE

Trademark Results [Nit-Vu]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NIT-VU
NIT-VU
77457264 3659067 Live/Registered
AngioDynamics, Inc.
2008-04-24

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