THERAGENICS CORPORATION

Address:5203 BRISTOL INDUSTRIAL WAY,BUFORD,GA,30518,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Source, Brachytherapy, Radionuclide (KXK) (10)

Premarket Exempt

No Yes

Clear

TheraSleeve® with I-Seed - 00813787020419 Catalog Number :

Device Description : TheraSleeve with x = 1-20 seeds and 0 or more spacers

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraSleeve® with I-Seed - 00813787020433 Catalog Number :

Device Description : TheraSleeve with x = 1-12 seeds and 0 or more markers

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraStrand® with I-Seed - 00813787020440 Catalog Number :

Device Description : Loose TheraStrand® with 1-6 seeds, standard spacing for CN

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraStrand® with I-Seed - 00813787020457 Catalog Number :

Device Description : Loose TheraStrand® with 1-6 seeds, standard spacing, in TPSII Ind. for CN

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraStrand® with I-Seed - 00813787020464 Catalog Number :

Device Description : TheraStrand with x = 1-12 seeds and 0 or more spacers for CN

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraLoad® with I-Seed - 00813787020471 Catalog Number :

Device Description : TheraLoad with x = 1-20 seeds and 0 or more spacers for CN

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraSleeve® with I-Seed - 00813787020495 Catalog Number :

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

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraSeed - 00813787020518 Catalog Number :

Device Description : Loose seeds in a vial for 3rd party processing

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraSeed - 00813787020525 Catalog Number :

Device Description : High activity loose seeds for the Eye

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraSeed - 00813787020532 Catalog Number :

Device Description : High activity loose seeds for the Eye – STERILE

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

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