TheraSleeve® with TheraSeed®

GUDID 00813787020969

TheraSleeve with x = 1-20 seeds and 0 or more spacers for CN

THERAGENICS CORPORATION

Manual brachytherapy source, permanent implant
Primary Device ID00813787020969
NIH Device Record Keybac0ac30-25e0-425f-a736-731446f2ef04
Commercial Distribution Discontinuation2016-10-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTheraSleeve® with TheraSeed®
Version Model NumberXX92x
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
GS100813787020969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00813787020969]

Radiation Sterilization


[00813787020969]

Radiation Sterilization


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 [TheraSleeve® with TheraSeed® ]

00813787020969TheraSleeve with x = 1-20 seeds and 0 or more spacers for CN
00813787020907TheraSleeve with x = 1-12 seeds and 0 or more markers
00813787020884TheraSleeve with x = 1-20 seeds and 0 or more spacers

Trademark Results [TheraSleeve]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THERASLEEVE
THERASLEEVE
78777841 3255101 Live/Registered
Theragenics Corporation
2005-12-21

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