THERAGENICS CORPORATION

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

TheraSeed - 00813787020006 Catalog Number :

Device Description : Loose seeds in a vial

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraSeed - 00813787020013 Catalog Number :

Device Description : Loose seeds in a vial - STERILE

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

I-Seed Agx100 - 00813787020020 Catalog Number :

Device Description : Loose seeds in a vial

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

I-Seed Agx100 - 00813787020037 Catalog Number :

Device Description : Loose seeds in a vial - STERILE

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

I-Seed Agx100 - 00813787020044 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

I-Seed Agx100 - 00813787020051 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

I-Seed Agx100 - 00813787020068 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

I-Seed Agx100 - 00813787020075 Catalog Number :

Device Description : Mick magazines in TPS x = (8)15, or (9)10 seeds per mag

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

I-Seed Agx100 - 00813787020082 Catalog Number :

Device Description : Mick magazines in TPS x = (8)15, or (9)10 seeds per mag - STERILE

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

I-Seed Agx100 - 00813787020099 Catalog Number :

Device Description : Mick magazines in TPSII Ind. x = (8)15, or (9)10 seeds per mag - STERILE

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

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