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

Lubricant, patient (KMJ) (5) Tray, catheterization, sterile urethral, with or without catheter (kit) (FCM) (5)

Premarket Exempt

Yes No

Clear

Surgilube - 00851809002449 Catalog Number : 281020536

Device Description : Sterile Surgical Lubricant, Metal Tube

Device Class :

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : KMJ

Prescription Use : No

Device Count : 1

Surgilube - 00851809002456 Catalog Number : 281020537

Device Description : Sterile Surgical Lubricant, Tube

Device Class : 1

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : KMJ

Prescription Use : No

Device Count : 1

Surgilube - 00851809002463 Catalog Number : 281020555

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 - 00851809002470 Catalog Number : 281020557

Device Description : Sterile Surgical Lubricant, Packet

Device Class :

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : KMJ

Prescription Use : No

Device Count : 1

HR Lubricating Jelly - 00851809002500 Catalog Number : 205ST

Device Description : Sterile Lubricating Jelly, Packet with SafeWrap®

Device Class : 1

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : KMJ

Prescription Use : No

Device Count : 1

TruCath - 00851809002524 Catalog Number : CK10

Device Description : TruCath Closed System Catheter Kit

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : FCM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002531 Catalog Number : CK12

Device Description : TruCath Closed System Catheter Kit

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : FCM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002548 Catalog Number : CK14

Device Description : TruCath Closed System Catheter Kit

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : FCM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002555 Catalog Number : CK16

Device Description : TruCath Closed System Catheter Kit

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : FCM

Prescription Use : Yes

Device Count : 1

TruCath - 00851809002562 Catalog Number : CSC10

Device Description : TruCath Closed System catheter

Device Class : 2

Duns Number: 828918164

Premarket Exempt : No

Product Code : FCM

Prescription Use : Yes

Device Count : 1

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