TheraStrand® with TheraSeed®

GUDID 00813787020785

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

THERAGENICS CORPORATION

Manual brachytherapy source, permanent implant
Primary Device ID00813787020785
NIH Device Record Keydfff59e2-cccf-4a95-bf8a-bb9d67309062
Commercial Distribution StatusIn Commercial Distribution
Brand NameTheraStrand® with TheraSeed®
Version Model NumberXX7215N
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
GS100813787020785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00813787020785]

Ethylene Oxide


[00813787020785]

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 TheraSeed®]

00813787020938TheraStrand with x = 1-12 seeds and 0 or more spacers for CN
00813787020921Loose TheraStrand with 1-6 seeds, standard spacing, in TPSII Ind. for CN
00813787020914Loose TheraStrand with 1-6 seeds, standard spacing for CN
00813787020853TheraStrand with 10 seeds and 0 or spacers in Mesh
00813787020846TheraStrand with x = 1-12 seeds and 0 or more spacers
00813787020839Loose TheraStrand with 1-6 seeds, standard spacing, in TPSII Ind.
00813787020822Loose TheraStrand with 1-6 seeds, standard spacing
00813787020792TheraStrand TSL in Flatpack – 15 stranded seeds per mag- STERILE
00813787020785TheraStrand TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
00813787020778TheraStrand 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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