PASCAL COMPANY, INC.

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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

Evacuator, Oral Cavity (EHZ) (5) Cleaners, Medical Devices (MDZ) (4) Sterilant, Medical Devices (MED) (1)

Premarket Exempt

No Yes

Clear

Banicide Plus Sterilizing and Disinfecting Solution - 00310866000008 Catalog Number : 15200

Device Description : Reusable 3.4% Glutaraldehyde Sterilizing & Disinfecting Solution; 1 gallonSteril Reusable 3.4% Glutaraldehyde Sterilizing & Disinfecting Solution; 1 gallonSterilization, high level disinfection and cleaning/decontamination solution.

Device Class :

Duns Number: 009260217

Premarket Exempt : No

Product Code : MED

Prescription Use : No

Device Count : 1

Citrizyme 300g - 00310866000015 Catalog Number : 15250

Device Description : Ultra Concentrated Enzymatic Evacuation Cleaner and Instrument Pre-Soak With the Ultra Concentrated Enzymatic Evacuation Cleaner and Instrument Pre-Soak With the Deodorizing Power of Baking Soda.Orange Scented; Dual Enzymes; Non-Corrosive; Non-Foaming; Biodegradable; Non-Toxic; Makes 35 gallons of cleaner. 300g Pouch

Device Class : 2

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MDZ

Prescription Use : No

Device Count : 1

Citrizyme Ultra Concentrated Enzyme Powder 50 Pouches - 00310866000022 Catalog Number : 15260

Device Description : Ultra Concentrated Enzymatic Evacuation Cleaner and Instrument Pre-Soak 50 Packets

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MDZ

Prescription Use : No

Device Count : 50

Citrizyme Ultra Concentrated Enzymatic Powder 900g - 00310866000039 Catalog Number : 15270

Device Description : Ultra concentrated enzymatic evacuation cleaner and instrument pre-soak; orange Ultra concentrated enzymatic evacuation cleaner and instrument pre-soak; orange scented, non foaming, non toxic, noncorrosive, 900 g pouch

Device Class : 2

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MDZ

Prescription Use : No

Device Count : 1

Citrizyme Ultra Concentrated Enzyme Powder 250 Packets - 00310866000046 Catalog Number : 15275

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MDZ

Prescription Use : No

Device Count : 250

Oratip Adapter - 00310866000121 Catalog Number : 24080

Device Description : Oratip adapter designed to fit all high volume oral evacuation systems

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 1

Oratip I Kit Dispoable Oral Evacuation Tips - 00310866000138 Catalog Number : 24105

Device Description : Disposable oral evacuation tips and one Oratip adapter, 72 tips

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 72

Oratip II Dispoable Oral Evacuation Tips - 25 tips - 00310866000145 Catalog Number : 24200

Device Description : Disposable oral evacuation tips, 25 tips

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 72

Oratip II Kit Dispoable Oral Evacuation Tips - 50 tips - 00310866000152 Catalog Number : 24205

Device Description : Disposable oral evacuation tips, 25 tips and one adapter

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 50

Oratip III Disposable Oral Evacuation Tips - 00310866000169 Catalog Number : 24250

Device Description : Disposable oral evacuation tips, 50 tips

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 50

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