40004 PercuNav Coaxial Needle Tracker, 17G x 16 cm

GUDID 00884838083004

Philips Ultrasound, Inc.

Multi-purpose stereotactic surgery system
Primary Device ID00884838083004
NIH Device Record Key89a4da26-f786-41a4-8867-cc9af592cdd9
Commercial Distribution StatusIn Commercial Distribution
Brand Name40004 PercuNav Coaxial Needle Tracker, 17G x 16 cm
Version Model Number989605428014
Company DUNS063377717
Company NamePhilips Ultrasound, Inc.
Device Count2
DM Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838083004 [Primary]
GS100884838083097 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00884838083004]

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Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-25

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