Head Frame Cranial Screws - Long and Short

GUDID 10858086006280

Contains one 10858086006266 Cranial Screws, Long, Pouch of 2 and one 10858086006273 Cranial Screws, Short, 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	10858086006280
NIH Device Record Key	483dc247-ca44-403f-8774-b4349cd3c6aa
Commercial Distribution Status	In Commercial Distribution
Brand Name	Head Frame Cranial Screws - Long and Short
Version Model Number	P1006801006
Company DUNS	009120817
Company Name	VARIAN MEDICAL SYSTEMS, INC.
Device Count	1
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	false
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	00858086006283 [Primary]
GS1	10858086006280 [Package] Contains: 00858086006283 Package: Case [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180586

FDA Product Code

IYE	Accelerator, linear, medical