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

Polymer Patient Examination Glove (LZA) (7) Accessory, Surgical Apparel (LYU) (1) Dressing, Wound, Drug (FRO) (1) Garment, Protective, For Incontinence (EYQ) (1)

Premarket Exempt

No Yes

Clear

Abena - 00190509001742 Catalog Number :

Device Description : Silver Calcium Alginate Dressing

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : FRO

Prescription Use : No

Device Count : 1

Abena - 00190509001971 Catalog Number :

Device Description : Abena Essentials washable chair underpads which measures 18" x 18".

Device Class :

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 00810049810191 Catalog Number :

Device Description : 4-ply mask

Device Class : 1

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

Abena - 00810049810443 Catalog Number :

Device Description : Nitrile Powder Free Medical Examination Gloves size 6-7 (Small).

Device Class : 1

Duns Number: 078740398

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Abena - 00810049810450 Catalog Number :

Device Description : Nitrile Powder Free Medical Examination Gloves size 7-8 (Medium).

Device Class : 1

Duns Number: 078740398

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Abena - 00810049810467 Catalog Number :

Device Description : Nitrile Powder Free Medical Examination Gloves size 7-8 (Medium).

Device Class : 1

Duns Number: 078740398

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Abena - 00810049810474 Catalog Number :

Device Description : Nitrile Powder Free Medical Examination Gloves size 9-10 (X-Large).

Device Class : 1

Duns Number: 078740398

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Abena - 00850001271493 Catalog Number :

Device Description : Nitrile Powder Free Medical Examination Gloves size 5-6 (XS).

Device Class : 1

Duns Number: 078740398

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Abena - 00850001271516 Catalog Number :

Device Description : Nitrile Powder Free Medical Examination Gloves size 6-7 (S).

Device Class : 1

Duns Number: 078740398

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Abena - 00850001271530 Catalog Number :

Device Description : Nitrile Powder Free Medical Examination Gloves size 7-8 (Medium).

Device Class : 1

Duns Number: 078740398

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

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