PRODUITS DENTAIRES PIERRE ROLLAN

Address:ZI DU PHARE,MERIGNAC CEDEX Gironde,FR

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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

Clear

EXPASYL strawberry flavor - 03760243000713 Catalog Number : 261001

Device Description : Sulcular opening paste (x20 capsules).

Device Class :

Duns Number: 277657631

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 20

Expasyl cannulas - 03760243000720 Catalog Number : 261040

Device Description : Expasyl straight application cannulas x40 for EXPASYL paste (sulcular opening paste).

Device Class : U

Duns Number: 277657631

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 40

Expasyl cannulas - 03760243000737 Catalog Number : 261005

Device Description : Expasyl straight application cannulas x100 for EXPASYL paste (sulcular opening paste).

Device Class : U

Duns Number: 277657631

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 100

Expasyl cannulas - 03760243000744 Catalog Number : 261045

Device Description : Expasyl bended application cannulas x40 for EXPASYL paste (sulcular opening paste).

Device Class : U

Duns Number: 277657631

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 40

Expasyl cannulas - 03760243000751 Catalog Number : 261015

Device Description : Expasyl bended application cannulas x100 for EXPASYL paste (sulcular opening paste).

Device Class : U

Duns Number: 277657631

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 100

EXPASYL - 03760243000775 Catalog Number : 294100

Device Description : 6 capsules (sulcular opening paste) + 1 applicator + 12 application cannulas.

Device Class : U

Duns Number: 277657631

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Expasyl Applicator - 03760243000782 Catalog Number : 260900

Device Description : Manual applicator for Expasyl paste (sulcular opening paste).

Device Class :

Duns Number: 277657631

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

ACTEON - 03760243000935 Catalog Number : 246050

Device Description : HEMOSTASYL is an original paste to be used as a haemostatic dressing with a mech HEMOSTASYL is an original paste to be used as a haemostatic dressing with a mechanical action.Box with 2 x 2g multiple use syringes of HEMOSTASYL paste

Device Class :

Duns Number: 277657631

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

ACTEON - 03760243000942 Catalog Number : 246100

Device Description : box with 40 angled application cannulas for Hemostasyl paste in syringe

Device Class : U

Duns Number: 277657631

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

ACTEON - 03760243000959 Catalog Number : 246200

Device Description : HEMOSTASYL is a paste to be used as a haemostatic dressing with a mechanical act HEMOSTASYL is a paste to be used as a haemostatic dressing with a mechanical action.Kit containing: 2 x 2g syringes of HEMOSTASYL Paste (about 30 uses) and 40 HEMOSTASYL angled application cannulas.Syringe for multiple uses. Application cannulas for single use.

Device Class : U

Duns Number: 277657631

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

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