HOPKINS UNIFORM COMPANY

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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, RETENTION TYPE, BALLOON (EZL) (5) LAVAGE, JET (FQH) (2) ASSAY, GLYCOSYLATED HEMOGLOBIN (LCP) (1) CATHETER, COUDE (EZC) (1) Mask, surgical (FXX) (1)

Premarket Exempt

No Yes

Clear

Hopkins Medical Products® - 00817643020148 Catalog Number : 19939

Device Description : Disposable Procedure Mask Each

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020155 Catalog Number : 34203

Device Description : Foley Catheter 100% Silicone, 20Fr 30cc

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020162 Catalog Number : 34204

Device Description : Foley Catheter 100% Silicone , 24Fr 30cc

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020179 Catalog Number : 34205

Device Description : Foley Catheter 100% Silicone, 14Fr 5cc

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020186 Catalog Number : 34206

Device Description : Foley Catheter 100% Silicone, 16Fr 5cc

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020193 Catalog Number : 34207

Device Description : Foley Catheter 100% Silicone, 24Fr 5cc

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020209 Catalog Number : 34210

Device Description : Saline Wound Wash 7.1 Oz Spray Can Safewash

Device Class : 2

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020216 Catalog Number : 34211

Device Description : Wound Cleanser No Rinse 8 Oz Pump Dermaklenz

Device Class : 2

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020223 Catalog Number : 34265

Device Description : A1CNow+ and 20-Test Kit

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : LCP

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020230 Catalog Number : 34266

Device Description : Lubricath 16Fr 5cc Foley Catheter

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : EZC

Prescription Use : No

Device Count : 1

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