Leak Stop Channel Marker - Channel 12 - 25 pack Not Sold Separately

GUDID 00816389028616

VARIAN MEDICAL SYSTEMS, INC.

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID00816389028616
NIH Device Record Key9a8abdc1-1e4d-41ae-895a-29c657ff2a20
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeak Stop Channel Marker - Channel 12 - 25 pack
Version Model NumberChannel 12
Catalog NumberNot Sold Separately
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100816389028616 [Unit of Use]
GS110816389028613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


[00816389028616]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-12-18
Device Publish Date2020-11-11

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