TOPCO ASSOCIATES, LLC

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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

Gauze / Sponge,Nonresorbable For External Use (NAB) (6) Dressing, Wound, Hydrophilic (NAC) (2) Latex Patient Examination Glove (LYY) (1) Tape And Bandage, Adhesive (KGX) (1)

Premarket Exempt

No Yes

Clear

Topco - 00036800185548 Catalog Number : TOP4025V1

Device Description : latex powder free exam gloves

Device Class : 1

Duns Number: 072943876

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 1

TopCare health - 00036800186002 Catalog Number :

Device Description : Waterproof Adhesive Tape, 1/2 IN x 10 YDS (1.27 cm x 9.1 m)

Device Class : 1

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

TopCare health - 00036800186781 Catalog Number :

Device Description : Sterile Non-Stick Pads, all one size, 3 IN x 4 IN (7.6 cm x 10.1 cm)

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 10

TopCare health - 00036800186798 Catalog Number :

Device Description : Sterile Gauze Pads, all one size, 3 IN x 3 IN

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 10

TopCare health - 00036800186804 Catalog Number :

Device Description : Sterile Rolled Gauze, 1 roll, 4 IN x 2 1/2 YDS

Device Class : 1

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

TopCare health - 00036800186811 Catalog Number :

Device Description : Sterile Gauze Pads, all one size, 4 IN x 4 IN (10.1 cm x 10.1 cm)

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 24

TopCare health - 00036800187207 Catalog Number :

Device Description : Sterile Gauze Pads, all one size, 3 IN x 3 IN

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 25

TopCare health - 00036800188204 Catalog Number :

Device Description : Sterile Rolled Gauze, 1 roll, 2 in x 2 1/2 YDS

Device Class : 1

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

TopCare health - 00036800196384 Catalog Number :

Device Description : Sterile Rolled Gauze, 3 IN x 2 1/2 YD (7.6 cm x 2.28 m)

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 5

TopCare health - 00036800196391 Catalog Number :

Device Description : Sterile, Non-Stick Pads, all one size, 2 IN x 3 IN

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 10

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