Pencil probe BP8M05S8A

GUDID 00894912002883

Reusable CW Doppler pencil probe, 8 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 ID00894912002883
NIH Device Record Key0094f64e-ef89-48a5-94c3-9ec7e0071b64
Commercial Distribution StatusIn Commercial Distribution
Brand NamePencil probe
Version Model NumberBP8M05S8A
Catalog NumberBP8M05S8A
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100894912002883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOPTransducer, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

[00894912002883]

Hydrogen Peroxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-04-07
Device Publish Date2018-04-10

On-Brand Devices [Pencil probe]

00894912002883Reusable CW Doppler pencil probe, 8 MHz
00894912002890Reusable CW Doppler pencil probe, 10 MHz
00894912002876Reusable CW Doppler pencil probe, 5 MHz
00894912002715Reusable CW Doppler pencil probe for HD307, 8 MHz
00894912002708Reusable CW Doppler pencil probe for HD307, 10 MHz
00894912002418Reusable CW Doppler pencil probe, 8 MHz
00894912002401Reusable CW Doppler pencil probe, 5 MHz
00894912002395Reusable CW Doppler pencil probe, 10 MHz
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