Fixation screw with nut for Cervix Applicator Set GM11005230

GUDID 00816389023567

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389023567
NIH Device Record Key8fdf6975-4721-46f0-9273-3e57b3f243b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixation screw with nut for Cervix Applicator Set
Version Model NumberGM11005230
Catalog NumberGM11005230
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
GS100816389023567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

Moist Heat or Steam Sterilization

[00816389023567]

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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