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) (10)

Premarket Exempt

No Yes

Clear

Advantage I-125® - M936IRLS12SSS9 Catalog Number :

Device Description : Radioactive seed localization, seed and spacer stranded.

Device Class :

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Advantage I-125® - M936IRLS20S0 Catalog Number : RSLN

Device Description : Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

Device Class : 2

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Advantage I-125® - M936IRLS20S9 Catalog Number :

Device Description : Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

Device Class : 2

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Advantage I-125® - M936IRLS20SS0 Catalog Number : RSLN

Device Description : Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

Device Class : 2

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Advantage I-125® - M936IRLS20SS9 Catalog Number : RSLN

Device Description : Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

Device Class : 2

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Advantage I-125® - M936IRLS20SSS0 Catalog Number : RSLN

Device Description : Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

Device Class : 2

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Advantage I-125® - M936IRLS20SSS9 Catalog Number : RSLN

Device Description : Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

Device Class : 2

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Advantage I-125® - M936IRLS9 Catalog Number :

Device Description : Radioactive seed localization needle, multi-lengths and configs

Device Class :

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Secure Strand with Advantage I-125 in Strand Delivery System - M936ISDS9 Catalog Number :

Device Description : Secure Strand with Advantage I-125 in Strand Delivery System

Device Class :

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

Advantage-Load® with Advantage Pd-103® - M936PBKAL9 Catalog Number :

Device Description : Advantage-Load® with Advantage Pd-103® radioactive seeds.

Device Class :

Duns Number: 002751241

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 9

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