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) (4) Lubricant, patient (KMJ) (4) Media, coupling, ultrasound (MUI) (2)

Premarket Exempt

Yes No

Clear

TruCath - 00851809002289 Catalog Number : CC1016

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 - 00851809002296 Catalog Number : CC1216

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 - 00851809002326 Catalog Number : CC1816

Device Description : TruCath intermittent Coude catheter

Device Class :

Duns Number: 828918164

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

RediCath - 00851809002340 Catalog Number : HS1416

Device Description : RediCath Hydrophilic Catheter

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

EcoVue HV - 00851809002364 Catalog Number : 383

Device Description : Non-Sterile Ultrasound Gel High Viscosity

Device Class :

Duns Number: 828918164

Premarket Exempt : No

Product Code : MUI

Prescription Use : Yes

Device Count : 1

EcoVue HV - 00851809002371 Catalog Number : 386

Device Description : Non-Sterile Ultrasound Gel High Viscosity

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : MUI

Prescription Use : Yes

Device Count : 1

Surgilube - 00851809002401 Catalog Number : 281020543

Device Description : Sterile Surgical Lubricant, Packet

Device Class : 1

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : KMJ

Prescription Use : No

Device Count : 1

Surgilube - 00851809002418 Catalog Number : 281020545

Device Description : Sterile Surgical Lubricant, Packet

Device Class : 1

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : KMJ

Prescription Use : No

Device Count : 1

Surgilube - 00851809002425 Catalog Number : 281020502

Device Description : Sterile Surgical Lubricant, Metal Tube

Device Class : 1

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : KMJ

Prescription Use : No

Device Count : 1

Surgilube - 00851809002432 Catalog Number : 281020512

Device Description : Sterile Surgical Lubricant, Tube

Device Class : 1

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : KMJ

Prescription Use : No

Device Count : 1

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