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

Dilator, Nasal (LWF) (2) Tape And Bandage, Adhesive (KGX) (2) Thermometer, Electronic, Clinical (FLL) (2) Pads, Menstrual, Scented-Deodorized (NRC) (1) Pad, Menstrual, Unscented (HHD) (1) Gauze / Sponge,Nonresorbable For External Use (NAB) (1) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (1)

Premarket Exempt

No Yes

Clear

TopCare health - 00036800084483 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 : 25

TOPCARE - 00036800092501 Catalog Number : 87-621-000

Device Description : DIGITAL THERMOMETER PROBE COVERS ORAL

Device Class : 2

Duns Number: 072943876

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Topcare One Step Pregnancy Test - 00036800115668 Catalog Number :

Device Description : FPPL Topcare SPS +/-

Device Class :

Duns Number: 072943876

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

TOPCARE - 00036800115811 Catalog Number :

Device Description : MINI SHIELD UNSCENTED 22CNT

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 22

TOPCARE - 00036800116870 Catalog Number :

Device Description : MINI SHIELD SCENTED 22CNT

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : NRC

Prescription Use : No

Device Count : 22

TopCare health - 00036800117976 Catalog Number :

Device Description : Sterile Butterfly Closures, all one size, 1 3/4 IN x 3/8 IN

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 12

TopCare health - 00036800118072 Catalog Number :

Device Description : Drug Free Nasal Strips, Medium, Clear Strips

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 30

TopCare health - 00036800118089 Catalog Number :

Device Description : Drug Free Nasal Strips, Large, Tan Strips

Device Class :

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 30

TOPCARE - 00036800118126 Catalog Number : 87-207-000

Device Description : INSTANT EAR THERMOMETER

Device Class : 2

Duns Number: 072943876

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TopCare health - 00036800118911 Catalog Number :

Device Description : Waterproof Adhesive Tape, 1 IN x 5 YDS (2.5 cm x 4.5 m)

Device Class : 1

Duns Number: 072943876

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

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