FDA.reportPublic FDA data

Varian Head Frame Package

Primary DI
00899475002196
Brand
Varian Head Frame Package
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
P1006805002
Device description
Head Frame Kit, Couch Adapter, SCCB, 20 Short + 20 Long Cranial Screws
Published
2016-09-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142560000Varian Head FrameVarian Medical Systems, Inc.2014-12-11IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899475002196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899475002196008994750021968994750021960899475002196

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic radiosurgical invasive head frameA device intended to be affixed to a patient's skull to enable precise localization of an area within the brain targeted for radiosurgical procedures (e.g., radiation treatment of a brain tumour). It is typically an assembly that includes a head ring or a head frame that is attached to the patient's head with fixation screws partially-embedded into the skull, an arc mechanism for setting target coordinates, and localizer frames and adaptors for precision placement to the simulator and imaging system [e.g., computed tomography (CT), magnetic resonance imaging (MRI), linear accelerator]. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009120817
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

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