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) Sterilant, medical devices (MED) (2) Indicator, physical/chemical sterilization process (JOJ) (1)

Premarket Exempt

No Yes

Clear

Sporox ® II - D687751901 Catalog Number :

Device Description : Sporox® II Sterilizing & Disinfecting Solution, 8 oz bottles, 6 pack

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : MED

Prescription Use : Yes

Device Count : 6

SPOROX® - D687751951 Catalog Number :

Device Description : Sporox® Test Vials - Contains: 30 test vials, 1 bottle of indicator solution, 1

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : JOJ, MED

Prescription Use : Yes

Device Count : 1

ASSUREPlus® - D687830001 Catalog Number :

Device Description : ASSUREPlus® 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

ASSUREPlus® - D687830011 Catalog Number :

Device Description : ASSUREPlus® Self-Sealing Sterilization Pouch 2.25 x 4 (57mm x 102mm) Box of 200

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 200

ASSUREPlus® - D687830031 Catalog Number :

Device Description : ASSUREPlus® 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

ASSUREPlus® - D687830051 Catalog Number :

Device Description : ASSUREPlus® 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

ASSUREPlus® - D687830101 Catalog Number :

Device Description : ASSUREPlus® Self-Sealing Sterilization Pouch 5.5 x 11 (140mm x 279mm) Box of 200

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 200

ASSUREPlus® - D687830151 Catalog Number :

Device Description : ASSUREPlus® Self-Sealing Sterilization Pouch 7 x 13 (178mm x 330mm) Box of 200

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 200

ASSUREPlus® - D687830201 Catalog Number :

Device Description : ASSUREPlus® Self-Sealing Sterilization Pouch 10 x 15 (254mm x 381mm) Box of 200

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 200

ASSUREPlus® - D687830251 Catalog Number :

Device Description : ASSUREPlus® Self-Sealing Sterilization Pouch 12 x 18 (305mm x 457mm) Box of 100

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 100

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