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

System, Applicator, Radionuclide, Manual (IWJ) (6) Source, Brachytherapy, Radionuclide (KXK) (4)

Premarket Exempt

No Yes

Clear

Theragenics - 00813787021607 Catalog Number :

Device Class : 1

Duns Number: 114379522

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

Theragenics - 00813787021614 Catalog Number :

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Theragenics - 00813787021638 Catalog Number :

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Theragenics - 00813787021652 Catalog Number :

Device Description : Bio Spacer 910 5.5mm, Nonsterile, QTY 150

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Theragenics - 00813787021669 Catalog Number :

Device Description : Bio Spacer 910 5.0mm, Nonsterile, QTY 50

Device Class : 2

Duns Number: 114379522

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Theragenics - 00813787021737 Catalog Number :

Device Description : 18ga x 20cm Brachytherapy Applicator Needle, Yellow

Device Class : 1

Duns Number: 114379522

Premarket Exempt : No

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

Theragenics - 00813787021744 Catalog Number :

Device Description : 18ga x 20cm Brachytherapy Applicator Needle, Yellow

Device Class : 1

Duns Number: 114379522

Premarket Exempt : No

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

Theragenics - 00813787021751 Catalog Number :

Device Description : 18ga x 20cm Brachytherapy Applicator Needle, Yellow

Device Class : 1

Duns Number: 114379522

Premarket Exempt : No

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

Theragenics - 00813787021768 Catalog Number :

Device Description : 18g 20cm Pre-waxed Brachytherapy Needle, 1 pack

Device Class : 1

Duns Number: 114379522

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

Theragenics - 00813787021775 Catalog Number :

Device Description : 18g 20cm Pre-waxed Brachytherapy Needle, 5 pack

Device Class : 1

Duns Number: 114379522

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

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