HR PHARMACEUTICALS INC.

Address:3630 Concord Rd,York,PA,17402,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

CATHETER, URETHRAL (GBM) (9) Media,coupling,ultrasound (MUI) (1)

Premarket Exempt

Yes No

Clear

HR Ultrasound Jelly - 00851809002180 Catalog Number : 218

Device Description : Non-Sterile Ultrasound Gel

Device Class : 2

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 1

RediCath - 00851809002197 Catalog Number : HS1216

Device Description : RediCath Hydrophilic Catheter

Device Class :

Duns Number: 828918164

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002203 Catalog Number : SC0806

Device Description : TruCath intermittent straight female catheter

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002210 Catalog Number : SC1006

Device Description : TruCath intermittent straight female catheter

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002227 Catalog Number : SC1206

Device Description : TruCath intermittent straight female catheter

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002234 Catalog Number : SC1406

Device Description : TruCath intermittent straight female catheter

Device Class :

Duns Number: 828918164

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002241 Catalog Number : SC1406NC

Device Description : TruCath intermittent straight female catheter (no connector)

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002258 Catalog Number : SC1606

Device Description : TruCath intermittent straight female catheter

Device Class :

Duns Number: 828918164

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002265 Catalog Number : CC1416

Device Description : TruCath intermittent Coude catheter

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002272 Catalog Number : CC1616

Device Description : TruCath intermittent Coude catheter

Device Class :

Duns Number: 828918164

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

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