Rochester Medical Corporation

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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

Catheter care tray (OHR) (3)

Premarket Exempt

No Yes

Clear

Magic3™ Hydrophilic Intermittent Catheter, Male - 00801741072666 Catalog Number : 53616GS

Device Description : Magic3™ Hydrophilic Intermittent Catheter, Male

Device Class : 2

Duns Number: 605440718

Premarket Exempt : Yes

Product Code : OHR

Prescription Use : Yes

Device Count : 1

Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male - 00801741072697 Catalog Number : 53512GS

Device Description : Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male

Device Class : 2

Duns Number: 605440718

Premarket Exempt : Yes

Product Code : OHR

Prescription Use : Yes

Device Count : 1

Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male - 00801741072703 Catalog Number : 53514GS

Device Description : Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male

Device Class : 2

Duns Number: 605440718

Premarket Exempt : Yes

Product Code : OHR

Prescription Use : Yes

Device Count : 1

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