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) Dilator, Nasal (LWF) (2) Gauze / Sponge,Nonresorbable For External Use (NAB) (2)

Premarket Exempt

No Yes

Clear

Core Values - 00017276223798 Catalog Number :

Device Description : Adhesive Bandages, Plastic, 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 : 60

Core Values - 00017276223828 Catalog Number :

Device Description : Premium Adhesive Bandages, Fabric, Antibacterial, assorted sizes, 5/8 IN x 2 1/4 Premium Adhesive Bandages, Fabric, Antibacterial, assorted sizes, 5/8 IN x 2 1/4 IN (15 MM x 57 MM), 3/4 IN x 3 IN (19 MM x 76 MM), 1 IN x 3 IN (25 MM x 76 MM)

Device Class :

Duns Number: 804085293

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 30

Core Values - 00017276224702 Catalog Number :

Device Description : Premium Adhesive Bandages, Fabric, Antibacterial, all one size, 3/4 IN x 3 IN (1 Premium Adhesive Bandages, Fabric, 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 : 30

Core Values - 00017276224719 Catalog Number :

Device Description : Adhesive Bandages, Sheer, Antibacterial, Extra Large, all one size, 2 IN x 4 IN Adhesive Bandages, Sheer, 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 - 00017276224894 Catalog Number :

Device Description : Drug-Free Nasal Strips, Tan Large

Device Class :

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 30

Core Values - 00017276224900 Catalog Number :

Device Description : Drug-Free Nasal Strips, Clear Medium

Device Class :

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 30

Core Values - 00017276225402 Catalog Number :

Device Description : Premium Adhesive Bandages, Waterproof Strong Strips, Antibacterial, all one size Premium Adhesive Bandages, Waterproof Strong Strips, Antibacterial, all one size, 1 IN x 3 1/4 IN (25 MM x 82 MM)

Device Class :

Duns Number: 804085293

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 20

Core Values - 00017276225419 Catalog Number :

Device Description : Waterproof Adhesive Tape, 1/2 IN x 10 YDS (1.27 cm x 9.1 m)

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Core Values - 00017276225426 Catalog Number :

Device Description : Gauze Pads, 3 IN x 3 IN (76 mm x 76 mm)

Device Class :

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 25

Core Values - 00017276225747 Catalog Number :

Device Description : Gauze Pads, 4 IN x 4 IN (101 mm x 101 mm)

Device Class :

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 10

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