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) (8) Calibrator, Dose, Radionuclide (KPT) (2)

Premarket Exempt

No Yes

Clear

I-Seed Agx100 - 00813787020204 Catalog Number :

Device Description : In-STANT magazines in TPSII Ind. - 20 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 - 00813787020211 Catalog Number :

Device Description : IsoLoader magazines in TPSII - 20 seeds per mag

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

I-Seed Agx100 - 00813787020228 Catalog Number :

Device Description : C20 IsoLoader magazines in TPSII – 20 seeds per mag

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

I-Seed Agx100 - 00813787020235 Catalog Number :

Device Description : IsoLoader magazines in TPSII - 20 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 - 00813787020242 Catalog Number :

Device Description : C20 IsoLoader magazines in TPSII – 20 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 - 00813787020259 Catalog Number :

Device Description : IsoLoader magazines in TPSII Ind. - 20 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 - 00813787020266 Catalog Number :

Device Description : C20 IsoLoader magazines in TPSII Ind. – 20 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 - 00813787020273 Catalog Number :

Device Description : C20 in TPSII Single x = 10, 15 or 20 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 - 00813787020280 Catalog Number :

Device Description : Seeds for IsoCartridge - STERILE

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

I-Seed Agx100 - 00813787020297 Catalog Number :

Device Description : Seeds for IsoStrand - STERILE

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

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