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) (7) Dressing, Wound, Hydrophilic (NAC) (3)

Premarket Exempt

No Yes

Clear

TIELLE® SILICONE BORDER - 15051978005759 Catalog Number : TLSB2122EN

Device Description : Hydropolymer Dressing with Silicone

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

TIELLE® SILICONE BORDER - 15051978006053 Catalog Number : TLSB0709EN

Device Description : Hydropolymer Dressing with Silicone

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

BIOCLUSIVE® PLUS - 15051978006428 Catalog Number : BIP0607

Device Description : Transparent Film Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

BIOCLUSIVE® PLUS - 15051978006435 Catalog Number : BIP1012

Device Description : Transparent Film Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

BIOCLUSIVE® PLUS - 15051978006442 Catalog Number : BIP1520

Device Description : Transparent Film Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

BIOCLUSIVE® PLUS - 15051978006459 Catalog Number : BIP2030

Device Description : Transparent Film Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

TIELLE® NON ADHESIVE - 15051978008293 Catalog Number : TLN1212EN

Device Description : Non Adhesive Hydropolymer Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : Yes

Device Count : 1

BIOSORB® - 15051978008422 Catalog Number : BGF0505U

Device Description : Gelling Fiber Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

BIOSORB® - 15051978008439 Catalog Number : BGF1012U

Device Description : Gelling Fiber Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

BIOSORB® - 15051978008446 Catalog Number : BGF1515U

Device Description : Gelling Fiber Dressing

Device Class : 1

Duns Number: 211352227

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

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