Head Frame - Post Assembly Set

GUDID 00858086006290

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame

Primary Device ID	00858086006290
NIH Device Record Key	a3bbcaff-bd6b-4734-8010-5c4036609d72
Commercial Distribution Status	In Commercial Distribution
Brand Name	Head Frame - Post Assembly Set
Version Model Number	P1008016004
Company DUNS	009120817
Company Name	VARIAN MEDICAL SYSTEMS, INC.
Device Count	4
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	00858086006290 [Unit of Use]
GS1	10858086006297 [Primary]
GS1	20858086006294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180586

FDA Product Code

IYE	Accelerator, linear, medical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

[00858086006290]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-01-25
Device Publish Date	2021-01-16

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

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10856100006223 - Gating Reflector Block	2024-12-11
00850800006074 - Vitesee	2024-11-11
00858086006467 - Varian Collimator Accessories 30 CM wedge set lower (JITKIT)	2024-10-07
00858086006474 - Varian Collimator Accessories 30 CM wedge set upper (JITKIT)	2024-10-07
00858086006481 - Varian Collimator Accessories 20 cm wedge set lower	2024-10-07
00858086006498 - Varian Collimator Accessories Lead wedge set lower (JITKIT)	2024-10-07

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