T10M5S8C T10M5S8C

GUDID 00894912002425

10 MHz curly cable clinic CW Doppler probe.

KOVEN TECHNOLOGY, INC.

Noninvasive vascular ultrasound system probe
Primary Device ID00894912002425
NIH Device Record Key95b9ed62-99ed-4658-a3b8-fff52ccb2688
Commercial Distribution StatusIn Commercial Distribution
Brand NameT10M5S8C
Version Model NumberT10M5S8C
Catalog NumberT10M5S8C
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100894912002425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOPTransducer, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-11-03
Device Publish Date2016-03-10

Devices Manufactured by KOVEN TECHNOLOGY, INC.

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00894912002203 - PGV-202023-11-03 PPG and Pulse Volume combo module for Smartdops.
00894912002296 - BF8M15S8A2023-11-03 8 MHz flat clinic CW Doppler probe.
00894912002302 - BT10M5S8A2023-11-03 10 MHz straight cable clinic CW Doppler probe.
00894912002319 - BT10M5S8C2023-11-03 10 MHz curly cable clinic CW Doppler probe.
00894912002333 - BT5M05S8A2023-11-03 5 MHz straight cable clinic CW Doppler probe.
00894912002340 - BT5M05S8C2023-11-03 5 MHz curly cable clinic CW Doppler probe.

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