HeadFrame Kit, Couch Adapter, SCCB Kit, & 20 Short + 20 Long Head Screws

GUDID 00858086006313

Contains one 10858086006280 Cranial Screws, Case of 10 Boxes of 2 Short + 2 Long; one 00858086006252 Headframe Kit; and one Couch Adapter

VARIAN MEDICAL SYSTEMS, INC.

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Primary Device ID	00858086006313
NIH Device Record Key	f7d39d18-e2da-4ba1-aa93-cb5e6390339f
Commercial Distribution Status	In Commercial Distribution
Brand Name	HeadFrame Kit, Couch Adapter, SCCB Kit, & 20 Short + 20 Long Head Screws
Version Model Number	P1006805006
Company DUNS	009120817
Company Name	VARIAN MEDICAL SYSTEMS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858086006313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180586

FDA Product Code

IYE	Accelerator, linear, medical