Derma Sciences Canada Inc

Address:104 SHORTING RD.,TORONTO Ontario,CA

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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

Strip, adhesive, closure, skin (FPX) (5) Gauze / sponge,nonresorbable for external use (NAB) (3) BANDAGE, CAST (ITG) (1) Dressing, wound, hydrophilic (NAC) (1)

Premarket Exempt

No Yes

Clear

TCC-EZ® - 00809958000076 Catalog Number : TCC2GSII

Device Description : TOTAL CONTACT CAST SYSTEM - MedE-Kast GSII - 10 Casting Systems

Device Class : 1

Duns Number: 200564891

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : Yes

Device Count : 1

Suture Strip® - 00809958000083 Catalog Number : DERMA-TS3101B

Device Description : Suture strip Wound Closure Strips

Device Class :

Duns Number: 200564891

Premarket Exempt : No

Product Code : FPX

Prescription Use : No

Device Count : 100

Suture Strip® - 00809958000113 Catalog Number : DERMA-TS3102B

Device Description : Suture strip Wound Closure Strips

Device Class :

Duns Number: 200564891

Premarket Exempt : No

Product Code : FPX

Prescription Use : No

Device Count : 100

Suture Strip® - 00809958000144 Catalog Number : DERMA-TS3103B

Device Description : Suture strip Wound Closure Strips

Device Class :

Duns Number: 200564891

Premarket Exempt : No

Product Code : FPX

Prescription Use : No

Device Count : 100

Suture Strip® - 00809958000175 Catalog Number : DERMA-TS3104B

Device Description : Suture strip Wound Closure Strips

Device Class :

Duns Number: 200564891

Premarket Exempt : No

Product Code : FPX

Prescription Use : No

Device Count : 100

Shur Strip® - 00809958000205 Catalog Number : DKC71153

Device Description : Shur Strip Wound Closure Strips Non-Sterile (Bulk)

Device Class :

Duns Number: 200564891

Premarket Exempt : No

Product Code : FPX

Prescription Use : No

Device Count : 1100

DuCare® - 00809958000236 Catalog Number : DUP3478

Device Description : Rayon Balls, Large. Bulk

Device Class :

Duns Number: 200564891

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1000

Gazetex® - 00809958000243 Catalog Number : DUP4500L

Device Description : Gazetex 1.5 in X 2 in diameter "krinkle" type prep sponge. Large with twisted kn Gazetex 1.5 in X 2 in diameter "krinkle" type prep sponge. Large with twisted knot. Bulk packed 400/case

Device Class :

Duns Number: 200564891

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 400

Gazetex® - 00809958000250 Catalog Number : DUP4501-M

Device Description : 2 in diameter Gazetex prep sponge with tail. Large with twisted knot. Sterile.

Device Class :

Duns Number: 200564891

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1000

SorbaCell® - 00809958000267 Catalog Number : DUP84501

Device Description : 4 in X 4 in Foam Tracheostomy dressing. Sterile

Device Class :

Duns Number: 200564891

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 10

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