ALPHA PRO TECH INC

ALPHA PRO TECH 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

Mask, Surgical (FXX) (10)

Premarket Exempt

No Yes

Clear

TUTEM - 00817583020352 Catalog Number : 6055-1 Social Butterfly

Device Description : EARLOOP, TUTEM -SOCIAL BUTTERFLY

Device Class : 2

Duns Number: 003687733

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Tutem - 00817583020369 Catalog Number : 6055-2 Business Class

Device Description : EARLOOP, TUTEM-BUSINESS CLASS

Device Class : 2

Duns Number: 003687733

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

TUTEM - 00817583020376 Catalog Number : 6055-3 DON'T GO VIRAL

Device Description : EARLOOP, TUTEM-DON'T GO VIRAL

Device Class : 2

Duns Number: 003687733

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

TUTEM - 00817583020383 Catalog Number : 6055-4 MICROBE MANAGER

Device Description : EARLOOP, TUTEM-MICROBE MANAGER

Device Class : 2

Duns Number: 003687733

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

TUTEM - 00817583020390 Catalog Number : 6055-5 COLD COUTURE

Device Description : EARLOOP, TUTEM-COLD COUTURE.

Device Class : 2

Duns Number: 003687733

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

TUTEM - 00817583020406 Catalog Number : 6055-6 KEEP IT TO YOURSELF

Device Description : EARLOOP, TUTEM- KEEP IT TO YOURSELF.

Device Class : 2

Duns Number: 003687733

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

TUTEM - 00817583020413 Catalog Number : 6055-7 GENTLE MANNERS

Device Description : EARLOOP, TUTEM-GENTLE MANNERS

Device Class : 2

Duns Number: 003687733

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

TUTEM - 00817583020420 Catalog Number : 6055-8 MASK TRANSIT

Device Description : EARLOOP, TUTEM-MASK TRANSIT

Device Class : 2

Duns Number: 003687733

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

TUTEM - 00817583020437 Catalog Number : 6055-9 BABY BOY

Device Description : EARLOOP, TUTEM-BABY BOY

Device Class : 2

Duns Number: 003687733

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

TUTEM - 00817583020444 Catalog Number : 6055-10 BABY GIRL

Device Description : EARLOOP, TUTEM-BABY GIRL.

Device Class : 2

Duns Number: 003687733

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

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