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

Sterilization wrap containers, trays, cassettes & other accessories (KCT) (8) VARNISH, CAVITY (LBH) (2)

Premarket Exempt

No Yes

Clear

ASSUREPlus® - D687830451 Catalog Number :

Device Description : ASSUREPlus® Self-Sealing Sterilization Pouch 5.5 x 13 (140mm x 330mm) Box of 200

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 200

ASSUREPlus® - D687830751 Catalog Number :

Device Description : ASSUREPlus® Self-Sealing Sterilization Pouch 5.25 x 7.5 (133mm x 191mm) Box of 200

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 200

ASSUREPlus® - D687830801 Catalog Number :

Device Description : ASSUREPlus® Self-Sealing Sterilization Pouch 11 x 16 (279mm x 406mm) Box of 100

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 100

PeelPro® - D687880001 Catalog Number :

Device Description : PeelPro® Self-Sealing Sterilization Pouch 2.75 x 10 (70mm x 254mm) Box of 200

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 200

PeelPro® - D687880051 Catalog Number :

Device Description : PeelPro® Self-Sealing Sterilization Pouch 3.25 x 6.5 (83mm x 165mm) Box of 200

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 200

PeelPro® - D687880101 Catalog Number :

Device Description : PeelPro® Self-Sealing Sterilization Pouch 3.5 x 10 (89mm x 254mm) Box of 200

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 200

PeelPro® - D687880151 Catalog Number :

Device Description : PeelPro® Self-Sealing Sterilization Pouch 5.25 x 11 (133mm x 279mm) Box of 200

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 200

PeelPro® - D687880201 Catalog Number :

Device Description : PeelPro® Self-Sealing Sterilization Pouch 7.5 x 13 (191mm x 330mm) Box of 200

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 200

Durashield® - D687AD311011 Catalog Number :

Device Description : Durashield® 5% Sodium Fluoride Varnish, Bubble Fun® 32 units of 0.40mL

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 32

Durashield® - D687AD311021 Catalog Number :

Device Description : Durashield® 5% Sodium Fluoride Varnish, Bubble Fun® 200 units of 0.40mL

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 200

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