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

Pad, Menstrual, Unscented (HHD) (3) Bandage, Elastic (FQM) (2) Gauze / Sponge,Nonresorbable For External Use (NAB) (2) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (1) Lubricant, Personal (NUC) (1) Tape And Bandage, Adhesive (KGX) (1)

Premarket Exempt

No Yes

Clear

TOPCARE - 00036800057463 Catalog Number :

Device Description : REGULAR MULTI-CHANNEL WINGLESS MAXIPAD UNSCENTED 24CNT

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 24

TopCare health - 00036800059931 Catalog Number :

Device Description : Tender Tape, 1 roll, 1 IN x 5 YDS (2.5 m x 4.5 m) stretched; 1 IN x 2 1/5 YDS (2 Tender Tape, 1 roll, 1 IN x 5 YDS (2.5 m x 4.5 m) stretched; 1 IN x 2 1/5 YDS (2.5 cm x 2 m) unstretched

Device Class : 1

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : FQM

Prescription Use : No

Device Count : 1

TopCare health - 00036800059948 Catalog Number :

Device Description : Tender Tape, 1 roll, 2 IN x 5 YDS (5 cm x 4.5 m) stretched; 2 IN x 2 1/5 YDS (5 Tender Tape, 1 roll, 2 IN x 5 YDS (5 cm x 4.5 m) stretched; 2 IN x 2 1/5 YDS (5 cm x 2 m) unstretched

Device Class : 1

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : FQM

Prescription Use : No

Device Count : 1

Topcare One Step Pregnancy Test - 00036800060937 Catalog Number :

Device Description : FPPL Topcare DPS +/-

Device Class :

Duns Number: 072943876

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Top Care - 00036800062115 Catalog Number :

Device Description : Lubricating Jelly4oz. (113g)

Device Class :

Duns Number: 072943876

Premarket Exempt : No

Product Code : NUC

Prescription Use : No

Device Count : 1

TopCare health - 00036800072657 Catalog Number :

Device Description : Sterile Rolled Gauze, 1 roll, 3 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 - 00036800079182 Catalog Number :

Device Description : Sterile Gauze Pads, all one size, 2 IN x 2 IN

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 10

TOPCARE - 00036800083790 Catalog Number :

Device Description : OVERNIGHT ULTRA THIN MAXIPAD W/ WINGS UNSCENTED 28CNT

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 28

TOPCARE - 00036800083806 Catalog Number :

Device Description : LONG SUPER ULTRA THIN MAXIPAD W/ WINGS UNSCENTED 32CNT

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 32

TopCare health - 00036800084469 Catalog Number :

Device Description : High Quality Sports Tape, 1 1/2 IN x 10 YDS (3.8 cm x 9.1 m)

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 4

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