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) (8) Dilator, Nasal (LWF) (1) Gauze / Sponge,Nonresorbable For External Use (NAB) (1)

Premarket Exempt

No Yes

Clear

Core Values - 00017276226607 Catalog Number :

Device Description : Gauze Pads, 2 IN x 2 IN (50 mm x 50 mm)

Device Class :

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 10

Core Values - 00017276226614 Catalog Number :

Device Description : Paper Tape, roll, 1 IN x 10 YDS (25 mm x 9.14 m)

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Core Values - 00017276226621 Catalog Number :

Device Description : Cloth Tape, 1 IN x 10 YDS (25 mm x 9.14 m)

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Core Values - 00017276226638 Catalog Number :

Device Description : Clear Tape, 1 IN x 10 YDS (25 mm x 9.14 m)

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Core Values - 00017276227956 Catalog Number :

Device Description : Premium Adhesive Bandages, Strong Strips, Antibacterial, all one size, 1 IN x 3 Premium Adhesive Bandages, 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 - 00017276227963 Catalog Number :

Device Description : Premium Adhesive Bandages, Strong Strips, Antibacterial, all one size, Extra Lar Premium Adhesive Bandages, Strong Strips, Antibacterial, all one size, Extra Large, 1 3/4 IN x 4 IN (44 MM x 101 MM)

Device Class :

Duns Number: 804085293

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 10

Core Values - 00017276227970 Catalog Number :

Device Description : Premium Adhesive Bandages, Clear Water Shield, Antibacterial, assorted sizes, 3/ Premium Adhesive Bandages, Clear Water Shield, Antibacterial, assorted sizes, 3/4 IN x 2 IN (19 MM x 50 MM), 1 IN x 2 1/2 IN (25 MM x 63 MM)

Device Class :

Duns Number: 804085293

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 30

Core Values - 00017276227987 Catalog Number :

Device Description : Premium Adhesive Bandages, Variety Pack, Antibacterial, assorted, Foam Bandages Premium Adhesive Bandages, Variety Pack, Antibacterial, assorted, Foam Bandages 5/8 IN x 2 1/4 IN (15 MM x 57 MM), Water Shield Bandages 1 IN x 2 1/2 IN (25 MM x 63 MM), Strong Strips Bandages 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 : 30

Core Values - 00017276227994 Catalog Number :

Device Description : Premium Adhesive Bandages, Foam, Antibacterial, all one size 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 - 00017276228014 Catalog Number :

Device Description : Extra Strength Nasal Strips, Tan Strips

Device Class :

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 26

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