HARMON STORES, 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) (6) Gauze / Sponge,Nonresorbable For External Use (NAB) (2) Dressing, Wound, Hydrophilic (NAC) (1) Dressing, Wound, Occlusive (NAD) (1)

Premarket Exempt

No Yes

Clear

Core Values - 00017276226485 Catalog Number :

Device Description : Premium Adhesive Bandages, Fabric, Antibacterial, Extra Large, all one size, 2 I Premium Adhesive Bandages, Fabric, Antibacterial, Extra Large, all one size, 2 IN x 4 IN (50 MM x 101 MM)

Device Class :

Duns Number: 804085293

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 10

Core Values - 00017276226492 Catalog Number :

Device Description : Adhesive Pads, Sheer, Antibacterial, Extra Large, 3 IN x 4 IN (76 MM x 101 MM)

Device Class :

Duns Number: 804085293

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 10

Core Values - 00017276226508 Catalog Number :

Device Description : Adhesive Pads Water Shield, Extra Large, 3 IN x 4 IN (76 MM x 101 MM)

Device Class :

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 6

Core Values - 00017276226515 Catalog Number :

Device Description : Non-Stick Pads, 3 IN x 4 IN (76 mm x 101 mm)

Device Class :

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 10

Core Values - 00017276226522 Catalog Number :

Device Description : Premium Adhesive Bandages, Waterproof Strong Strips, Antibacterial, Extra Large, Premium Adhesive Bandages, Waterproof Strong Strips, Antibacterial, Extra Large, all one size, 2 IN x 4 IN (50 MM x 101 MM)

Device Class :

Duns Number: 804085293

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 10

Core Values - 00017276226546 Catalog Number :

Device Description : Adhesive Bandages, Sheer, Antibacterial, assorted sizes, 7/8 (22 MM), 5/8 IN x 2 Adhesive Bandages, Sheer, Antibacterial, assorted sizes, 7/8 (22 MM), 5/8 IN x 2 1/4 IN (15 MM x 57 MM), 3/4 IN x 3 IN (19 MM x 76 MM), 2 1/4 IN x 3 IN (57 MM x 76 MM)

Device Class :

Duns Number: 804085293

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 80

Core Values - 00017276226553 Catalog Number :

Device Description : Adhesive Bandages, Sheer, Antibacterial, all one size, 3/4 IN x 3 IN (19 MM x 76 MM)

Device Class :

Duns Number: 804085293

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 40

Core Values - 00017276226560 Catalog Number :

Device Description : Premium Adhesive Bandages, Advanced Healing Technology, all one size, 1 1/8 IN x Premium Adhesive Bandages, Advanced Healing Technology, all one size, 1 1/8 IN x 2 3/8 IN (28 mm x 60 mm)

Device Class :

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 6

Core Values - 00017276226584 Catalog Number :

Device Description : Rolled Gauze, roll, 2 IN x 2.5 YDS (50 mm x 2.28 m)

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

Core Values - 00017276226591 Catalog Number :

Device Description : Rolled Gauze, roll, 4 IN x 2.5 YDS (101 mm x 2.28 m)

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

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