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) (10)

Premarket Exempt

Yes No

Clear

Pascord Retraction Cord 8/0 - 00310866000497 Catalog Number : 07600

Device Description : Twisted Gingival Retraction cord with Aluminum Sulfate, 72 inches, Size: 8/0

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Pascord Retraction Cord 9/1 - 00310866000503 Catalog Number : 07610

Device Description : Twisted Gingival Retraction cord with Aluminum Sulfate, 72 inches, Size: 9/1

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Pascord Retraction Cord 10/2 - 00310866000510 Catalog Number : 07620

Device Description : Twisted Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 10/2

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Racord Retraction Cord 07/00 - 00310866000527 Catalog Number : 07697

Device Description : Twisted Gingival Retraction Cord with Epinephrine, 72 inches, Size: 07/00

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Racord Retraction Cord 8/0 - 00310866000534 Catalog Number : 07700

Device Description : Twisted Gingival Retraction Cord with Epinephrine, 72 inches, Size: 8/0

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Racord Retraction Cord 9/1 - 00310866000541 Catalog Number : 07710

Device Description : Twisted Gingival Retraction Cord with Epinephrine, 72 inches, Size: 9/1

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Racord Retraction Cord 10/2 - 00310866000558 Catalog Number : 07720

Device Description : Twisted Gingival Retraction Cord with Epinephrine, 72 inches, Size: 10/2

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Racord Two Retraction Cord 7/00 - 00310866000565 Catalog Number : 07797

Device Description : Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 i Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches,Size: 7/00

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Racord Two Retraction Cord 8/0 - 00310866000572 Catalog Number : 07800

Device Description : Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 i Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size: 8/0

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Racord Two Retraction Cord 9/1 - 00310866000589 Catalog Number : 07810

Device Description : Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 i Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size: 9/1

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

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