Sultan Healthcare 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

Com-Fit® - D687203361 Catalog Number :

Device Description : Super High Filtration com-fit® mask Tie-On Box of 40

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 40

Com-Fit® - D687203401 Catalog Number :

Device Description : Easy Breathe™ com-fit® mask Earloop Box of 40

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 40

Com-Fit® - D687203421 Catalog Number :

Device Description : Easy Breathe™ com-fit® mask Tie-On Box of 40

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 40

Com-Fit® - D687203441 Catalog Number :

Device Description : Super Sensitive com-fit® mask Tie-On Box of 50

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 50

Com-Fit® - D687203461 Catalog Number :

Device Description : Super Sensitive com-fit® mask Earloop Box of 50

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 50

Com-Fit® - D687203501 Catalog Number :

Device Description : Groovy Mask com-fit® mask Earloop Box of 40

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 40

Com-Fit® - D687203521 Catalog Number :

Device Description : com-fit Plush™ Masks CFP-1 Earloop Box of 40

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 40

Com-Fit® - D687203531 Catalog Number :

Device Description : com-fit Plush™ Masks CFP-2 Earloop Box of 40

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 40

Com-Fit® - D687203541 Catalog Number :

Device Description : com-fit Plush™ Masks CFP-3 Earloop Box of 40

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 40

Com-Fit® - D687203551 Catalog Number :

Device Description : Com-Fit Plush™ Natural Fit Masks ASTM #1 Box of 40

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 40

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