Ahold U.S.A., Inc.

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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

Tape And Bandage, Adhesive (KGX) (4) Dressing, Wound, Hydrophilic (NAC) (2) Gauze / Sponge,Nonresorbable For External Use (NAB) (2) Floss, Dental (JES) (1) Toothbrush, Powered (JEQ) (1)

Premarket Exempt

No Yes

Clear

CareOne - 00041520001061 Catalog Number :

Device Description : Floss Threaders

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 50

CareOne - 00041520010681 Catalog Number :

Device Description : Watershield Adhesive Pads, all one size, 3 IN x 4 IN

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 6

CareOne - 00041520010698 Catalog Number :

Device Description : Cloth Tape, 1 IN x 10 YDS

Device Class : 1

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

CareOne - 00041520010704 Catalog Number :

Device Description : Clear Tape, 1 IN x 10 YDS

Device Class : 1

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

CareOne - 00041520013880 Catalog Number :

Device Description : Non-Stick Pads, all one size, 3 IN x 4 IN

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 20

CareOne - 00041520013927 Catalog Number :

Device Description : Non-Stick Pads, all one size, 2 IN x 3 IN

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 20

CareOne - 00041520013958 Catalog Number :

Device Description : Premium, Rolled Gauze, rolls, 4 IN x 2.1 YDS (101 mm x 1.9 m)

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 5

CareOne - 00041520013965 Catalog Number :

Device Description : Premium, Rolled Gauze, rolls, 3 IN x 2.1 YDS (76 mm x 1.9 m)

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 5

CareOne - 00041520014009 Catalog Number :

Device Description : Waterproof Adhesive Tape, 1IN x 5YDS

Device Class : 1

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

CareOne - 00041520019660 Catalog Number :

Device Description : Power Toothbrush, Infinity, Easy Flex

Device Class : 1

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

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