Varian Head Frame Package

GUDID 00899475002196

Head Frame Kit, Couch Adapter, SCCB, 20 Short + 20 Long Cranial Screws

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame
Primary Device ID00899475002196
NIH Device Record Key4423f871-d5d1-4bd3-8c1b-9b4ea3a326c1
Commercial Distribution Discontinuation2018-07-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameVarian Head Frame Package
Version Model NumberP1006805002
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 Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100899475002196 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-09
Device Publish Date2016-09-10

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