Aarhus Applicator Set GM11013800

GUDID 00816389028050

Contains: GM11013810-00816389028036, GM11013820-00816389028043

VARIAN MEDICAL SYSTEMS, INC.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Primary Device ID00816389028050
NIH Device Record Key6deed8c4-33ad-44dd-817e-410f9c6181bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAarhus Applicator Set
Version Model NumberGM11013800
Catalog NumberGM11013800
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100816389028050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


[00816389028050]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-10
Device Publish Date2023-03-31

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