5.0 MHz Deep Vascular Probe

GUDID 00888937001372

For TRIA II Dopplers

Coopersurgical, Inc.

Noninvasive vascular ultrasound system probe
Primary Device ID00888937001372
NIH Device Record Keyf38475cb-04c2-4475-823b-147bc8dec1df
Commercial Distribution StatusIn Commercial Distribution
Brand Name5.0 MHz Deep Vascular Probe
Version Model NumberTSP-5
Company DUNS801895244
Company NameCoopersurgical, 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937001372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEPMonitor, Blood-Flow, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-31

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