PARAGON MEDICAL, INC.

Address:8 Matchett Dr.,PIERCETON,IN,46562,US

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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) (10)

Premarket Exempt

No Yes

Clear

Stryker Universal Select Sterilization Tray System - 00857387006404 Catalog Number :

Device Description : 1/4 DIN Silicone Mat

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006411 Catalog Number :

Device Description : 1/2 DIN Silicone Mat

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

ChestShield Sterilization Tray System - 00857387006428 Catalog Number :

Device Description : SternalPlate Instrument Tray 1

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

ChestShield Sterilization Tray System - 00857387006435 Catalog Number :

Device Description : SternalPlate Instrument Tray 2

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

ChestShield Sterilization Tray System - 00857387006442 Catalog Number :

Device Description : VariSpeed Tray

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

ChestShield Sterilization Tray System - 00857387006459 Catalog Number :

Device Description : ChestShield Instrument Tray Lid

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

ChestShield Sterilization Tray System - 00857387006466 Catalog Number :

Device Description : SternalPlate Implant Module with Lid

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

ChestShield Sterilization Tray System - 00857387006473 Catalog Number :

Device Description : Implant Module Lid

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

ChestShield Sterilization Tray System - 00857387006480 Catalog Number :

Device Description : SternalPlate Plate Inlay

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Sonopet iQ Sterilization Tray - 00857387006497 Catalog Number :

Device Description : Sonopet iQ Sterilization Tray

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

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