Varian Sterilization Box for Advanced Breast Template System GM11012150

GUDID 00816389028449

VARIAN MEDICAL SYSTEMS, INC.

Sterilization/disinfection container
Primary Device ID00816389028449
NIH Device Record Key60220a3a-b979-4c4b-82f6-25523bc957f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameVarian Sterilization Box for Advanced Breast Template System
Version Model NumberGM11012150
Catalog NumberGM11012150
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS100816389028449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-21
Device Publish Date2021-06-12

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