NP Probe NP10M2S8AF

GUDID 00894912002722

PW Bayonet style flexible tip Doppler probe, 10 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 Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe
Primary Device ID00894912002722
NIH Device Record Keyff956e5a-9ae8-4617-8e7f-6bec4e9da824
Commercial Distribution StatusIn Commercial Distribution
Brand NameNP Probe
Version Model NumberNP10M2S8AF
Catalog NumberNP10M2S8AF
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100894912002722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

[00894912002722]

Hydrogen Peroxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-07
Device Publish Date2016-06-29

On-Brand Devices [NP Probe]

00894912002944PW mid length bayonet style flexible tip Doppler probe, 20 MHz
00894912002746PW Bayonet style Doppler probe, 20 MHz
00894912002739PW Bayonet style flexible tip Doppler probe, 20 MHz
00894912002722PW Bayonet style flexible tip Doppler probe, 10 MHz
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