Head Frame Cranial Screws, Short

GUDID 30858086006277

Pouch of 2

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame
Primary Device ID30858086006277
NIH Device Record Key1fe44268-20bf-4df5-b782-f626f93f2102
Commercial Distribution StatusIn Commercial Distribution
Brand NameHead Frame Cranial Screws, Short
Version Model NumberP1008070003
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
Device Count2
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858086006276 [Unit of Use]
GS110858086006273 [Primary]
GS120858086006270 [Package]
Contains: 10858086006273
Package: Box [2 Units]
In Commercial Distribution
GS130858086006277 [Package]
Contains: 20858086006270
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


[30858086006277]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-25
Device Publish Date2021-01-16

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