SMITH & NEPHEW MEDICAL LIMITED

Address:101 Hessle Road,HULL East Riding of Yorkshire,GB

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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

Dressing, Wound, Hydrogel Without Drug And/Or Biologic (NAE) (3) Solvent, Adhesive Tape (KOX) (3) Bandage, Liquid, Skin Protectant (NEC) (2) Bag, Drainage, With Adhesive, Ostomy (FON) (1) Dressing, Wound, Occlusive (NAD) (1)

Premarket Exempt

No Yes

Clear

Intrasite Gel Applipak 8g USA Ctn 10 - 00000050223473 Catalog Number : 66027308

Device Description : Hydrogel Wound Dressing

Device Class :

Duns Number: 216344051

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Intrasite Gel Applipak 15g USA Ctn 10 - 00000050223480 Catalog Number : 66027311, 7311

Device Description : Hydrogel Wound Dressing

Device Class :

Duns Number: 216344051

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Intrasite Gel Applipak 25g USA Ctn 10 - 00000050223497 Catalog Number : 66027313

Device Description : Hydrogel Wound Dressing

Device Class :

Duns Number: 216344051

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

UNI-SOLVE Wipes - 00040565111803 Catalog Number : 402300

Device Description : Adhesive Remover Wipe

Device Class :

Duns Number: 216344051

Premarket Exempt : Yes

Product Code : KOX

Prescription Use : No

Device Count : 1

REMOVE Wipes - 00040565111810 Catalog Number : 403100

Device Description : Universal Adhesive Remover Wipe

Device Class :

Duns Number: 216344051

Premarket Exempt : Yes

Product Code : KOX

Prescription Use : No

Device Count : 1

Tincture of Benzoin Spray 4oz US - 00040565111827 Catalog Number : 407000

Device Description : Tincture of Benzoin Skin Prep Spray is a skin prep spray that enhances the adhes Tincture of Benzoin Skin Prep Spray is a skin prep spray that enhances the adhesion of tape/appliance while protecting sensitive skin from adhesives and body fluids.

Device Class : 1

Duns Number: 216344051

Premarket Exempt : Yes

Product Code : FON

Prescription Use : No

Device Count : 1

SKIN-PREP 4oz Spray US - 00040565111841 Catalog Number : 420200

Device Description : Protective Spray

Device Class : 1

Duns Number: 216344051

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 1

REMOVE Adhesive Remover 8oz US - 00040565112435 Catalog Number : 403300

Device Description : Universal adhesive remover spray

Device Class : 1

Duns Number: 216344051

Premarket Exempt : Yes

Product Code : KOX

Prescription Use : No

Device Count : 1

SKIN-PREP Wipes - 00040565112695 Catalog Number : 420400, 420471

Device Description : Protective Wipe

Device Class :

Duns Number: 216344051

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 1

REPLICaRE 1.5X2.5IN (4X6CM) - 00040565114088 Catalog Number : 483000

Device Description : Hydrocolloid wound dressing

Device Class :

Duns Number: 216344051

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

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