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

Transurethral occlusion insert, urinary incontinence-control, female (OCK) (7) Catheter care tray (OHR) (3)

Premarket Exempt

No Yes

Clear

FemSoft® Insert Female Urethral Insert - 00801741011061 Catalog Number : 71201

Device Description : Female Urethral Insert

Device Class : 3

Duns Number: 605440718

Premarket Exempt : No

Product Code : OCK

Prescription Use : Yes

Device Count : 1

FemSoft® Insert Female Urethral Insert - 00801741011078 Catalog Number : 71202

Device Description : Female Urethral Insert

Device Class : 3

Duns Number: 605440718

Premarket Exempt : No

Product Code : OCK

Prescription Use : Yes

Device Count : 1

FemSoft® Insert Female Urethral Insert - 00801741011085 Catalog Number : 71203

Device Description : Female Urethral Insert

Device Class : 3

Duns Number: 605440718

Premarket Exempt : No

Product Code : OCK

Prescription Use : Yes

Device Count : 1

FemSoft® Insert Female Urethral Insert - 00801741011092 Catalog Number : 72201

Device Description : Female Urethral Insert

Device Class : 3

Duns Number: 605440718

Premarket Exempt : No

Product Code : OCK

Prescription Use : Yes

Device Count : 1

FemSoft® Insert Female Urethral Insert - 00801741011108 Catalog Number : 72202

Device Description : Female Urethral Insert

Device Class : 3

Duns Number: 605440718

Premarket Exempt : No

Product Code : OCK

Prescription Use : Yes

Device Count : 1

FemSoft® Insert Female Urethral Insert - 00801741011115 Catalog Number : 72203

Device Description : Female Urethral Insert

Device Class : 3

Duns Number: 605440718

Premarket Exempt : No

Product Code : OCK

Prescription Use : Yes

Device Count : 1

FemSoft® Insert Female Urethral Insert - 00801741011122 Catalog Number : 70200

Device Description : Female Urethral Insert

Device Class :

Duns Number: 605440718

Premarket Exempt : No

Product Code : OCK

Prescription Use : Yes

Device Count : 1

Magic3™ Hydrophilic Intermittent Catheter, Female - 00801741072499 Catalog Number : 51614S

Device Description : Magic3™ Hydrophilic Intermittent Catheter, Female

Device Class : 2

Duns Number: 605440718

Premarket Exempt : Yes

Product Code : OHR

Prescription Use : Yes

Device Count : 1

Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Female - 00801741072598 Catalog Number : 51514S

Device Description : Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Female

Device Class : 2

Duns Number: 605440718

Premarket Exempt : Yes

Product Code : OHR

Prescription Use : Yes

Device Count : 1

Magic3™ Hydrophilic Intermittent Catheter, Male - 00801741072659 Catalog Number : 53614GS

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

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