SYSTAGENIX WOUND MANAGEMENT, LIMITED

Address:3M Centre,Berkshire Bracknell Forest,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, Occlusive (NAD) (9) Dressing, Wound, Collagen (KGN) (1)

Premarket Exempt

Yes No

Clear

FIBRACOL® PLUS - 15051978001119 Catalog Number : 2984

Device Description : Collagen Wound Dressing with Alginate

Device Class : U

Duns Number: 211352227

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

TIELLE® - 15051978001133 Catalog Number : MTL100EN

Device Description : Hydropolymer Adhesive Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

TIELLE® - 15051978001164 Catalog Number : MTL101EN

Device Description : Hydropolymer Adhesive Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

TIELLE® PLUS HEEL - 15051978001263 Catalog Number : MTP508

Device Description : Hydropolymer Adhesive Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

TIELLE® MAX - 15051978001300 Catalog Number : MTP701

Device Description : Hydropolymer Non-Adhesive Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

TIELLE® MAX - 15051978001317 Catalog Number : MTP705

Device Description : Hydropolymer Non-Adhesive Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

TIELLE® MAX - 15051978001324 Catalog Number : MTP702

Device Description : Hydropolymer Non-Adhesive Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

NU-DERM® - 15051978002543 Catalog Number : HCB102

Device Description : Hydrocolloid Wound Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

NU-DERM® - 15051978002550 Catalog Number : HCB106

Device Description : Hydrocolloid Wound Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

NU-DERM® - 15051978002567 Catalog Number : HCS100

Device Description : Hydrocolloid Wound Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

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