VariStrand with OncoSeed

GUDID 00813787021232

VariStrand with OncoSeed, x = 1-12 seeds and 0 or more spacers

THERAGENICS CORPORATION

Manual brachytherapy source, permanent implant
Primary Device ID00813787021232
NIH Device Record Key64974206-0f0d-497f-99c5-3c4ce59fa521
Commercial Distribution StatusIn Commercial Distribution
Brand NameVariStrand with OncoSeed
Version Model NumberON772xi
Company DUNS114379522
Company NameTHERAGENICS CORPORATION
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813787021232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00813787021232]

Ethylene Oxide


[00813787021232]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-02-10

Devices Manufactured by THERAGENICS CORPORATION

00813787022253 - TheraMark™2022-06-02 TheraMark (AgX100 loose seed -12 cm ) - STERILE
00813787022260 - TheraMark™2022-06-02 TheraMark (TheraStrand with AgX100 -12 cm) - STERILE
00813787022277 - TheraMark™2022-06-02 TheraMark (TheraStrand with AgX100 -12 cm) - STERILE
00813787022284 - TheraMark™2022-06-02 TheraMark (AgX100 loose seed - 7 cm ) - STERILE
00813787022291 - TheraMark™2022-06-02 TheraMark (AgX100 loose seed - 5 cm ) - STERILE
00813787022307 - TheraMark™2022-06-02 TheraMark (TheraStrand with AgX100 - 7 cm) - STERILE
00813787022314 - TheraMark™2022-06-02 TheraMark (TheraStrand with AgX100 - 5 cm) - STERILE
00813787022321 - TheraMark™2022-06-02 TheraMark (Anchorseed with AgX100 - 7 cm) -STERILE

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