Derma Sciences Canada Inc

Address:104 SHORTING RD.,TORONTO Ontario,CA

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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

DRESSING, WOUND AND BURN, OCCLUSIVE (MGP) (7) Anoscope and accessories (FER) (2) GAUZE, EXTERNAL (WITH DRUG/BIOLOGIC/ANIMAL SOURCE MATERIAL) (GER) (1)

Premarket Exempt

No Yes

Clear

Shur-Conform® Oil Emulsion - 10381780491804 Catalog Number : DKC77044

Device Description : SHUR-CONFORM Oil Emulsion Non-Adhering Dressing – Sterile

Device Class : U

Duns Number: 200564891

Premarket Exempt : No

Product Code : GER

Prescription Use : Yes

Device Count : 1

DERMAGRAN®-B - 10381780491811 Catalog Number : DERMA-SPD03

Device Description : Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6 For Skin Ulcers (Dia Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6 For Skin Ulcers (Diabetic, Venous Stasis), and Stage I-IV Pressure Sores

Device Class : U

Duns Number: 200564891

Premarket Exempt : No

Product Code : MGP

Prescription Use : Yes

Device Count : 1

DERMAGRAN®-B - 10381780491828 Catalog Number : DERMA-SPD20

Device Description : Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6.

Device Class : U

Duns Number: 200564891

Premarket Exempt : No

Product Code : MGP

Prescription Use : Yes

Device Count : 1

DERMAGRAN®-B - 10381780491835 Catalog Number : DERMA-SPD21

Device Description : Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6.

Device Class : U

Duns Number: 200564891

Premarket Exempt : No

Product Code : MGP

Prescription Use : Yes

Device Count : 1

DERMAGRAN®-B - 10381780491842 Catalog Number : DERMA-SPD24

Device Description : Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6.

Device Class : U

Duns Number: 200564891

Premarket Exempt : No

Product Code : MGP

Prescription Use : Yes

Device Count : 1

PrimaDerm® - 10381780491859 Catalog Number : DUP69101

Device Description : PrimaDerm Dermal Cleanser (Preservative Free) 4 fl oz Bottle. Sterile

Device Class : U

Duns Number: 200564891

Premarket Exempt : No

Product Code : MGP

Prescription Use : Yes

Device Count : 1

PrimaDerm® - 10381780491866 Catalog Number : DUP69201

Device Description : PrimaDerm Wound Cleanser (Preserved). Non-Cytotoxic, No Rinse Formualtion. 16 fl PrimaDerm Wound Cleanser (Preserved). Non-Cytotoxic, No Rinse Formualtion. 16 fl oz bottle.

Device Class : U

Duns Number: 200564891

Premarket Exempt : No

Product Code : MGP

Prescription Use : Yes

Device Count : 1

PrimaDerm® - 10381780491873 Catalog Number : DUP69202

Device Description : PrimaDerm Wound Cleanser (Preserved). Non-Cytotoxic, No Rinse Formualtion. 4 fl oz bottle.

Device Class : U

Duns Number: 200564891

Premarket Exempt : No

Product Code : MGP

Prescription Use : Yes

Device Count : 1

Pak-its® - 10381780491880 Catalog Number : DUP59145

Device Description : 0.25 in X 5 yards gauze packing iodoform strip in bottles with dispenser insert.

Device Class : 2

Duns Number: 200564891

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Pak-its® - 10381780491897 Catalog Number : DUP59146

Device Description : 0.25 in X 5 yards gauze packing iodoform strip in bottles without dispenser insert.

Device Class : 2

Duns Number: 200564891

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

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