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, Drug (FRO) (2) Floss, Dental (JES) (2) Dilator, Nasal (LWF) (1) Toothbrush, Powered (JEQ) (1)

Premarket Exempt

No Yes

Clear

CareOne - 00041520059420 Catalog Number :

Device Description : Floss, waxed, 55YD

Device Class : 1

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

CareOne - 00041520059437 Catalog Number :

Device Description : Floss, unwaxed, 55YD

Device Class : 1

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

CareOne - 00041520059444 Catalog Number :

Device Description : Power Toothbrush, Smile Sonic Max Power Pro

Device Class : 1

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

CareOne - 00041520060969 Catalog Number :

Device Description : Drug Free Nasal Strips Extra Strength Clear

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 26

CareOne - 00041520078117 Catalog Number :

Device Description : Antibacterial Gauze Pads, all one size, 2 IN x 2 IN, 2 pads per wrapper. Contain Antibacterial Gauze Pads, all one size, 2 IN x 2 IN, 2 pads per wrapper. Contains: Polyhexamethylene Biguadine (PHMB) 0.2%

Device Class :

Duns Number: 170199058

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 20

CareOne - 00041520078179 Catalog Number :

Device Description : Antibacterial Bandage Roll, one roll, 4.5 IN x 4.1 YDS. Contains: Polyhexamethyl Antibacterial Bandage Roll, one roll, 4.5 IN x 4.1 YDS. Contains: Polyhexamethylene Biguadine (PHMB) 0.2%

Device Class : U

Duns Number: 170199058

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 1

CareOne - 00041520078193 Catalog Number :

Device Description : Waterproof Transparent Dressing, Wound Cover, all one size, 2.36 IN x 2.75 IN

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 8

CareOne - 00041520078209 Catalog Number :

Device Description : Heavy Duty Strong Strip Bandages Antibacterial, all one size, 1 IN x 3 1/4 IN

Device Class :

Duns Number: 170199058

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 60

CareOne - 00041520078223 Catalog Number :

Device Description : Assorted Waterproof Clear Bandages Antibacterial, 1 IN x 2 1/2 IN (25 mm x 63 mm Assorted Waterproof Clear Bandages Antibacterial, 1 IN x 2 1/2 IN (25 mm x 63 mm); 3/4 IN x 2 IN (19 mm x 50 mm); 3/4 IN x 1 1/2 IN (19 mm x 38 mm)

Device Class :

Duns Number: 170199058

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 20

CareOne - 00041520078230 Catalog Number :

Device Description : Extra Large Waterproof Clear Bandages, Antibacterial, all one size, 2 IN x 3 1/2 IN

Device Class :

Duns Number: 170199058

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 8

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