Myriad Medical, LLC

Address:2202 N West Shore Blvd Ste 200,Tampa,FL,33607,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

Prostate Immobilizer Rectal Balloon (PCT) (3) Syringe, Irrigating (Non Dental) (KYZ) (1)

Premarket Exempt

No Yes

Clear

Prostate Caddy Rectal Balloon - 10860005263100 Catalog Number : 3301

Device Description : Prostate Immobilization device. Rectal Balloon, single use, non-sterile. Box of 50.

Device Class : 2

Duns Number: 842448610

Premarket Exempt : No

Product Code : PCT

Prescription Use : Yes

Device Count : 50

Prostate Caddy Rectal Balloon - 10860005263117 Catalog Number : 3309

Device Description : Prostate Immobilization device. Rectal Balloon and inflation syringe, single us Prostate Immobilization device. Rectal Balloon and inflation syringe, single use, non-sterile. Kit Box of 25.

Device Class : 2

Duns Number: 842448610

Premarket Exempt : No

Product Code : PCT

Prescription Use : Yes

Device Count : 25

Prostate Caddy Rectal Balloon - 10860005263124 Catalog Number : 9901

Device Description : Prostate Immobilization device. Rectal Balloon with inflation syringe, single u Prostate Immobilization device. Rectal Balloon with inflation syringe, single use, non-sterile. Box of 25.

Device Class : 2

Duns Number: 842448610

Premarket Exempt : No

Product Code : PCT

Prescription Use : Yes

Device Count : 25

Inflation Luer Lock Syringe - 10860005263131 Catalog Number : 100

Device Description : 100 cc Inflation Syringe, single use, non-sterile. Box of 100.

Device Class : 1

Duns Number: 842448610

Premarket Exempt : Yes

Product Code : KYZ

Prescription Use : Yes

Device Count : 100

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