3D-FSD interstitial ovoid pair for 25mm spread with 6 needle guide holes/ovoid GM11010720

GUDID 00816389025585

For Titanium Fletcher-style Applicator Set Defined Geometry

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389025585
NIH Device Record Keyb8b9221f-2d9c-4bc7-8200-d9747114cddc
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D-FSD interstitial ovoid pair for 25mm spread with 6 needle guide holes/ovoid
Version Model NumberGM11010720
Catalog NumberGM11010720
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
GS100816389025585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

Moist Heat or Steam Sterilization


[00816389025585]

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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