DEVICE: Varian Head Frame Package (00899475002196)
Device Identifier (DI) Information
Varian Head Frame Package
P1006805002
Not in Commercial Distribution
VARIAN MEDICAL SYSTEMS, INC.
P1006805002
Not in Commercial Distribution
VARIAN MEDICAL SYSTEMS, INC.
Head Frame Kit, Couch Adapter, SCCB, 20 Short + 20 Long Cranial Screws
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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35361 | Stereotactic radiosurgical invasive head frame |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IYE | Accelerator, linear, medical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K142560 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4423f871-d5d1-4bd3-8c1b-9b4ea3a326c1
December 09, 2019
4
September 10, 2016
December 09, 2019
4
September 10, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined