GT MEDICAL TECHNOLOGIES, INC.

Address:1809 S Holbrook Ln,Tempe,AZ,85281,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

Shield, Protective, Personnel (KPY) (1) Source, Brachytherapy, Radionuclide (KXK) (1)

Premarket Exempt

No Yes

Clear

GammaTile™ - 00860000064507 Catalog Number :

Device Description : Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a puri Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier

Device Class :

Duns Number: 081299204

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

GammaTile Radiation Shielding Tray - 00860000064514 Catalog Number :

Device Class : 1

Duns Number: 081299204

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 1

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