DEVICE: Varian Head Frame Package (00899475002196)

Device Identifier (DI) Information

Varian Head Frame Package
P1006805002
Not in Commercial Distribution

VARIAN MEDICAL SYSTEMS, INC.
00899475002196
GS1
July 03, 2018
1
009120817 *Terms of Use
Head Frame Kit, Couch Adapter, SCCB, 20 Short + 20 Long Cranial Screws
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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IYE Accelerator, linear, medical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K142560 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4423f871-d5d1-4bd3-8c1b-9b4ea3a326c1
December 09, 2019
4
September 10, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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