TheraStrand® with I-Seed

GUDID 00813787020310

TheraStrand® TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE

THERAGENICS CORPORATION

Manual brachytherapy source, permanent implant
Primary Device ID00813787020310
NIH Device Record Key5c714ca3-6224-4b34-9ba4-c10fbfa01152
Commercial Distribution StatusIn Commercial Distribution
Brand NameTheraStrand® with I-Seed
Version Model NumberXX7215iN
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
GS100813787020310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00813787020310]

Ethylene Oxide


[00813787020310]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-21

On-Brand Devices [TheraStrand® with I-Seed]

00813787020464TheraStrand with x = 1-12 seeds and 0 or more spacers for CN
00813787020457Loose TheraStrand® with 1-6 seeds, standard spacing, in TPSII Ind. for CN
00813787020440Loose TheraStrand® with 1-6 seeds, standard spacing for CN
00813787020389TheraStrand with 10 seeds and 0 or spacers in Mesh
00813787020372TheraStrand® with x = 1-12 seeds and 0 or more spacers
00813787020365Loose TheraStrand® with 1-6 seeds, standard spacing, in TPSII Ind.
00813787020358Loose TheraStrand® with 1-6 seeds, standard spacing
00813787020327TheraStrand® TSL in Flatpack – 15 stranded seeds per mag- STERILE
00813787020310TheraStrand® TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
00813787020303TheraStrand® TSL in TPSII Single – 15 stranded seeds per mag- STERILE

Trademark Results [TheraStrand]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THERASTRAND
THERASTRAND
78067353 2978133 Live/Registered
Theragenics Corporation
2001-06-05

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