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

Floss, Dental (JES) (2) Gauze / Sponge,Nonresorbable For External Use (NAB) (1) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (1) Pad, Menstrual, Unscented (HHD) (1) Polymer Patient Examination Glove (LZA) (1) Radioimmunoassay, Luteinizing Hormone (CEP) (1) Tampon, Menstrual, Unscented (HEB) (1) Toothbrush, Powered (JEQ) (1) Vinyl Patient Examination Glove (LYZ) (1)

Premarket Exempt

No Yes

Clear

TopCare - 00036800156845 Catalog Number :

Device Description : Easy Flex Total Power Toothbrush

Device Class : 1

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

TopCare - 00036800156876 Catalog Number :

Device Description : 40M Extra Comfort Floss

Device Class : 1

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

Topcare - 00036800163201 Catalog Number :

Device Description : WWOT Topcare OVS

Device Class :

Duns Number: 072943876

Premarket Exempt : No

Product Code : CEP

Prescription Use : No

Device Count : 7

Topcare Digital Pregnancy Test - 00036800163218 Catalog Number :

Device Description : CB8 Digital Pregnancy Stick Topcare DPS Digital Early US

Device Class :

Duns Number: 072943876

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

TopCare health - 00036800165908 Catalog Number :

Device Description : Sterile Bandage Roll, 4 1/2 IN x 4 YD (11.4 cm x 3.6 m) (Stretched)

Device Class : 1

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

TopCare - 00036800174399 Catalog Number :

Device Description : 50M Hi-Tech Mint Floss

Device Class : 1

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

TOPCARE - 00036800182127 Catalog Number :

Device Description : REGULAR WINGLESS MAXIPAD UNSCENTED 24CNT

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 24

TopCare Tampons - 00036800185494 Catalog Number :

Device Class :

Duns Number: 072943876

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 18

Topco - 00036800185524 Catalog Number : TOP4045V1

Device Description : GLOVES EXAM NITRILE

Device Class : 1

Duns Number: 072943876

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Topco - 00036800185531 Catalog Number : TOP4035V1

Device Description : GLOVES EXAM VINYL POWDER FREE CLEAR

Device Class : 1

Duns Number: 072943876

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 1

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