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 - 00857387006107 Catalog Number :

Device Description : Plate Module

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006114 Catalog Number :

Device Description : Upper-/Mid-Face Instrument Tray

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006121 Catalog Number :

Device Description : Orbital Floor Instrument Tray

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006138 Catalog Number :

Device Description : MP Instrument Tray

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006145 Catalog Number :

Device Description : Mandible Fracture Instrument Tray

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006152 Catalog Number :

Device Description : Trocar Instrument Tray

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006169 Catalog Number :

Device Description : Mandible Reconstruction Instrument Tray

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006176 Catalog Number :

Device Description : 3-in-1 Mandible Reconstruction Bender Tray

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006183 Catalog Number :

Device Description : HMMF Instrument Tray

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006190 Catalog Number :

Device Description : 90° (Right Angle) Screwdriver Instrument Tray

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

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