Head Frame Cranial Screws, Long

GUDID 20858086006263

Pouch of 2

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame

Primary Device ID	20858086006263
NIH Device Record Key	cfa3e5f7-683e-41d8-a474-349963dfab7f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Head Frame Cranial Screws, Long
Version Model Number	P1008070004
Company DUNS	009120817
Company Name	VARIAN MEDICAL SYSTEMS, INC.
Device Count	2
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
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	00858086006269 [Unit of Use]
GS1	10858086006266 [Primary]
GS1	20858086006263 [Package] Contains: 10858086006266 Package: Box [2 Units] In Commercial Distribution
GS1	30858086006260 [Package] Package: Case [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180586

FDA Product Code

IYE	Accelerator, linear, medical