Cranial Screw - Long

GUDID 10899475002155

Cranial screw - long pouch - Qty 2

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame
Primary Device ID10899475002155
NIH Device Record Key88e1006c-2007-4bde-baf9-3e12eec2b372
Commercial Distribution StatusIn Commercial Distribution
Brand NameCranial Screw - Long
Version Model NumberP1008070002
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100899475002158 [Unit of Use]
GS110899475002155 [Primary]
GS120899475002152 [Package]
Package: Box [2 Units]
In Commercial Distribution
GS130899475002159 [Package]
Contains: 20899475002152
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-10

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