ISOAID, L.L.C.

Address:7824 CLARK MOODY BLVD.,PORT RICHEY,FL,34668,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) (9) Holder, Needle; Orthopedic (HXK) (1)

Premarket Exempt

No Yes

Clear

Guide Needle - M936BGNS0 Catalog Number :

Device Description : Brachytherapy Guide Needle

Device Class : 1

Duns Number: 002751241

Premarket Exempt : Yes

Product Code : HXK

Prescription Use : Yes

Device Count : 1

Advantage-Load® with Advantage I-125® - M936IBKAL9 Catalog Number :

Device Description : Advantage-Load® with I-125 radioactive seeds.

Device Class :

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Advantage-Strand® with Advantage I-125® - M936IBKAS9 Catalog Number :

Device Description : Brachytherapy Kit: Advantage-Strand® with I-125 radioactive seeds.

Device Class :

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Advantage-Strand® and Advantage-Load® with Advantage I-125® - M936IBKASAL9 Catalog Number :

Device Description : Brachytherapy Kit: Advantage-Strand® and Advantage-Load® with Advantage I-125® Brachytherapy Kit: Advantage-Strand® and Advantage-Load® with Advantage I-125® radioactive seeds.

Device Class :

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Secure Strand® with Advantage I-125® - M936IBKSS9 Catalog Number :

Device Description : Secure Strand with I-125 radioactive seeds.

Device Class :

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Advantage I-125® - M936IBKSSAL9 Catalog Number :

Device Description : Secure Strand and Advantage Load with I-125 radioactive seeds.

Device Class :

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Advantage I-125® - M936IEPS9 Catalog Number :

Device Description : Advantage I-125® radioactive seeds with a molded form that is shielded on one si Advantage I-125® radioactive seeds with a molded form that is shielded on one side and contains grooved positions for manual brachytherapy sources on the other side and is used for the temporary topical application of brachytherapy sources to the surface of the eye.

Device Class :

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Advantage I-125® - M936ILVN0 Catalog Number :

Device Description : Advantage I-125® radioactive seeds, Loose Load, Non-sterile

Device Class : 2

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Advantage I-125® - M936ILVN9 Catalog Number :

Device Description : Radioactive I-125 seeds, loose, in vial, non-sterile

Device Class :

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Advantage I-125® - M936ILVS0 Catalog Number :

Device Description : Advantage I-125® radioactive brachytherapy seeds.

Device Class : 2

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

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