Colpostat segment, 20mm diameter for three-channel Applicator Sets GM11000680

GUDID 00816389021631

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389021631
NIH Device Record Key4edb8824-9edd-4b08-90fe-6db1b7c611a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameColpostat segment, 20mm diameter for three-channel Applicator Sets
Version Model NumberGM11000680
Catalog NumberGM11000680
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
GS100816389021631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

Moist Heat or Steam Sterilization


[00816389021631]

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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