NDP Probe NDP-20

GUDID 00894912002609

PW Bayonet style Doppler probe, 20 MHz

KOVEN TECHNOLOGY, INC.

Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe
Primary Device ID00894912002609
NIH Device Record Key9c9ff752-8cfc-4104-a658-b266a446a278
Commercial Distribution StatusIn Commercial Distribution
Brand NameNDP Probe
Version Model NumberNDP-20
Catalog NumberNDP-20
Company DUNS069261402
Company NameKOVEN TECHNOLOGY, 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

Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100894912002609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-07
Device Publish Date2016-07-05

On-Brand Devices [NDP Probe]

00894912002609PW Bayonet style Doppler probe, 20 MHz
00894912002593PW Bayonet style Doppler probe, 10 MHz

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