EDGE Radiosurgery System

GUDID 00899475002257

VARIAN MEDICAL SYSTEMS, INC.

Linear accelerator system
Primary Device ID00899475002257
NIH Device Record Keya2005e22-e7fb-4e1c-b83d-f0e1b2a149de
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDGE Radiosurgery System
Version Model Number2.7
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100899475002257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-29
Device Publish Date2019-04-19

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