BV Endura 718075

GUDID 00884838055490

Mobile, diagnostic X-ray imaging and viewing system. Used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures.

Philips Medical Systems Nederland B.V.

Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital
Primary Device ID00884838055490
NIH Device Record Key11b94d4f-71e7-4625-bdc1-f74271453b5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBV Endura
Version Model NumberBV Endura
Catalog Number718075
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
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
GS100884838055490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-23
Device Publish Date2016-09-24

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