THERAGENICS CORPORATION

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

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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

Yes No

Clear

TheraStrand® with I-Seed - 00813787020303 Catalog Number :

Device Description : TheraStrand® TSL in TPSII Single – 15 stranded seeds per mag- STERILE

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraStrand® with I-Seed - 00813787020310 Catalog Number :

Device Description : TheraStrand® TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraStrand® with I-Seed - 00813787020327 Catalog Number :

Device Description : TheraStrand® TSL in Flatpack – 15 stranded 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 - 00813787020334 Catalog Number :

Device Description : Circular Seed Carrier where “mm” = 10, 12, 14, 16, 18, 20, or 22mm

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

I-Seed Agx100 - 00813787020341 Catalog Number :

Device Description : Notched Seed Carrier where “mm” = 10, 12, 14, 16, 18, 20, or 22mm

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraStrand® with I-Seed - 00813787020358 Catalog Number :

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

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraStrand® with I-Seed - 00813787020365 Catalog Number :

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

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraStrand® with I-Seed - 00813787020372 Catalog Number :

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

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraStrand® with I-Seed - 00813787020389 Catalog Number :

Device Description : TheraStrand with 10 seeds and 0 or spacers in Mesh

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

TheraLoad® with I-Seed - 00813787020396 Catalog Number :

Device Description : TheraLoad 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

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