Sultan Healthcare Inc

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) (5) VARNISH, CAVITY (LBH) (4) Sterilant, medical devices (MED) (1)

Premarket Exempt

No Yes

Clear

SPOROX II - D032751561 Catalog Number : 75156

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : MED

Prescription Use : No

Device Count : 1

Com-Fit - D6870020361SA1 Catalog Number :

Device Description : 0

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 3

Durashield® CV - D6870031103FG1 Catalog Number :

Device Description : Durashield® CV 5% Sodium Fluoride Clear Varnish Watermelon 50 Count of 0.40mL

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 50

Durashield® CV - D6870031104FG1 Catalog Number :

Device Description : Durashield® CV 5% Sodium Fluoride Clear Varnish Strawberry 50 Count of 0.40mL

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 50

Durashield® CV - D6870031105FG1 Catalog Number :

Device Description : Durashield® CV 5% Sodium Fluoride Clear Varnish Watermelon 200 Count of 0.40mL

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 200

Durashield® CV - D6870031106FG1 Catalog Number :

Device Description : Durashield® CV 5% Sodium Fluoride Clear Varnish Strawberry 200 Count of 0.40mL

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 200

Com-Fit® - D687203241 Catalog Number :

Device Description : Fluid Resistant Procedural Blue com-fit® mask Box of 50

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 50

Com-Fit® - D687203251 Catalog Number :

Device Description : Fluid Resistant Procedural Pink com-fit® mask Box of 50

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 50

Com-Fit® - D687203261 Catalog Number :

Device Description : Super High Filtration 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® - D687203281 Catalog Number :

Device Description : Super High Filtration with eyeshield com-fit® Earloop Box of 25

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 25

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