Head Frame Kit

GUDID 00858086006252

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame
Primary Device ID00858086006252
NIH Device Record Keybc586508-67d1-483e-9dc3-a1b467e6da44
Commercial Distribution StatusIn Commercial Distribution
Brand NameHead Frame Kit
Version Model NumberP1006823004
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS100858086006252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


[00858086006252]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-25
Device Publish Date2021-01-16

On-Brand Devices [Head Frame Kit]

00858086006252P1006823004
00858086006634P1006823005

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.