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 - 00857387006305 Catalog Number :

Device Description : 2.0 MP Standard Plates Inlay, Small

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006312 Catalog Number :

Device Description : 2.0 MP Le-Fort Plates Inlay

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006329 Catalog Number :

Device Description : 2.0/2.3 Mandible Screw 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 - 00857387006336 Catalog Number :

Device Description : 2.0/2.3 Mandible Plates 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 - 00857387006343 Catalog Number :

Device Description : 2.0/2.3 Mini Plates Inlay, Large

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006350 Catalog Number :

Device Description : 2.0/2.3 Mandible Recon Plates 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 - 00857387006367 Catalog Number :

Device Description : 2.0/2.3 Mandible Recon Primary Plates Inlay

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006374 Catalog Number :

Device Description : 2.0/2.3 Mandible Plates/Screws 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 - 00857387006381 Catalog Number :

Device Description : 2.0/2.3 Mini Plates Inlay, Small

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Stryker Universal Select Sterilization Tray System - 00857387006398 Catalog Number :

Device Description : 2.0 HMMF Plates/Screws Module

Device Class : 2

Duns Number: 609244454

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

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