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

Cord, Retraction (MVL) (7) Accessories, Retractor, Dental (EIF) (3)

Premarket Exempt

No Yes

Clear

Guyer 7A Packing Instrument, Shovel Head, Angled - 00310866000695 Catalog Number : 26141

Device Description : Retraction Cord Packing Instrument, Guyer 7A, Shovel Head, Angled

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 1

PT-55 Packing Instrument - 00310866000718 Catalog Number : 26135

Device Description : Retraction Cord Packing Instrument, Circlet instrument with serrated tip

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 1

Retrax Cord Cutter - 00310866000732 Catalog Number : 26440

Device Description : Stainless steel retraction cord cutter with micro serration. Autoclavable

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 1

Epidri Pellets - 00310866000770 Catalog Number : 12100

Device Description : Hemostatic cotton pellets with epinephrine, approx. 350 pellets

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 350

Racellet 2 Pellets - 00310866000787 Catalog Number : 12150

Device Description : Hemostatic cotton pellets with epinephrine; approx. 200 pellets

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 200

Racellet 3 Pellets - 00310866000794 Catalog Number : 12200

Device Description : Hemostatic cotton pellets with epinephrine; approx. 350 each

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 350

Retrax Pellets - 00310866000800 Catalog Number : 12400

Device Description : Hemostatic cotton pellets with aluminum sulfate

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 350

Retrax Solution 15 mL - 00310866000817 Catalog Number : 15600

Device Description : Flavored Hemostatic retraction solution for topical dental application with 25% Flavored Hemostatic retraction solution for topical dental application with 25% aluminum sulfate, 15 mL

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Retrax Solution 40 mL - 00310866000824 Catalog Number : 15610

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Gel Cord Clear Topical Hemostatic Gel ProPack - 00310866000831 Catalog Number : 15840

Device Description : 25% aluminum sulfate gel, 12 - 0.75g syringe; no color

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 12

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