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

Floss, Dental (JES) (8) Toothbrush, Powered (JEQ) (2)

Premarket Exempt

Yes No

Clear

Core Values - 00071031075282 Catalog Number :

Device Description : Floss, Tape, Mint, 100YD

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

Core Values - 00071031300070 Catalog Number :

Device Description : Floss, Unwaxed, 100YD

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

Core Values - 00071031300087 Catalog Number :

Device Description : Floss, Mint, 100YD

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

Core Values - 00071031438285 Catalog Number :

Device Description : Flosser, Compact Pick, Hi-Tech, Mint

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 36

Core Values - 00071031439282 Catalog Number :

Device Description : Flosser, Compact Pick, Hi-Tech, Unflavored

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 90

Core Values - 00071031524285 Catalog Number :

Device Description : Power Toothbrush, Pro Whitening, 2 replacement heads

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

Core Values - 00071031526289 Catalog Number :

Device Description : Power Toothbrush, Pro Clean, 2 replacement heads

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

Core Values - 00071031549288 Catalog Number :

Device Description : Floss, Extra Comfort, Mint, 40M

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

Core Values - 00071031689281 Catalog Number :

Device Description : Flosser, Curvy Pick, PTFE, Mint

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 90

Core Values - 00071031702287 Catalog Number :

Device Description : Flosser, Compact Pick, Hi-Tech, Mint

Device Class : 1

Duns Number: 804085293

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 150

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