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

Garment, Protective, For Incontinence (EYQ) (5) Dressing, Wound, Hydrophilic (NAC) (3) Dressing, Wound, Drug (FRO) (2)

Premarket Exempt

No Yes

Clear

Abena - 00190509001582 Catalog Number :

Device Description : Abena tuckable disposable underpad holds 50 fluid ounces/1700 ml and measures 28" x 70".

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 00190509001599 Catalog Number :

Device Description : Abena Essentials washable underpads with measurements of 30 x 36".

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 00190509001605 Catalog Number :

Device Description : Abena Essentials tuckable disposable underpads with measurements of 30" x 72".

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 00190509001612 Catalog Number :

Device Description : Abena Essentials washable Underpads that measures 35" x 42".

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 00190509001629 Catalog Number :

Device Description : Abena washable Adult Bib (with optional crumb catcher) with measurements of 18" x 18".

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 00190509001698 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 - 00190509001704 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 - 00190509001711 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 - 00190509001728 Catalog Number :

Device Description : Abena Silver Calcium Alginate Dressing-Sterile

Device Class :

Duns Number: 078740398

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 1

Abena - 00190509001735 Catalog Number :

Device Description : Abena Silver Calcium Alginate Dressing-Sterile

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : FRO

Prescription Use : No

Device Count : 1

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