ABENA NORTH AMERICA, INC.

Address:4551 Glencoe Ste 100,Marina del Rey,CA,90292,US

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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) (2) Garment, Protective, For Incontinence (EYQ) (1)

Premarket Exempt

No Yes

Clear

Abena - 00190509001384 Catalog Number :

Device Description : Silicone Foam Dressing with Film Backing

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Abena - 00190509001391 Catalog Number :

Device Description : Silicone Foam Dressing with Film Backing

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Abena - 00190509001407 Catalog Number :

Device Description : Silicone Foam Dressing with Film Backing

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Abena - 00190509001414 Catalog Number :

Device Description : Silicone Foam Dressing with Film

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Abena - 00190509001421 Catalog Number :

Device Description : Silicone Foam Dressing with Film Backing and Silicone

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Abena - 00190509001438 Catalog Number :

Device Description : Silicone Foam Dressing with Film Backing and Silicone Adhesive Border

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Abena - 00190509001445 Catalog Number :

Device Description : Silicone Foam Dressing with Film Backing and Silicone Adhesive Border

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Abena - 00190509001452 Catalog Number :

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Abena - 00190509001469 Catalog Number :

Device Description : Calcium Alginate Dressing

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Abena - 00190509001575 Catalog Number :

Device Description : Abena disposable underpad with adhesive strips holds 57 fluid ounces/1700 ml and Abena disposable underpad with adhesive strips holds 57 fluid ounces/1700 ml and measures 30" x 36".

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

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