Headless Screw Ti, Ovoid FSD (10) GM11007250

GUDID 00816389024106

For Titanium Fletcher-style Applicator Set Defined Geometry

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389024106
NIH Device Record Key092d4b3b-77e3-42ba-acde-67c5077218a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeadless Screw Ti, Ovoid FSD (10)
Version Model NumberGM11007250
Catalog NumberGM11007250
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
Device Count1
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 Datefalse
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
GS100816389024106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


[00816389024106]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-10
Device Publish Date2021-02-02

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