PARAGON 28, INC.

Address:44 Riverdale Avenue,Monmouth Bch,NJ,07750,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

Screw, fixation, bone (HWC) (10)

Premarket Exempt

No Yes

Clear

Gorilla Plating System - 00889795000316 Catalog Number : P50-053-3524

Device Description : 3.5 x 24 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000323 Catalog Number : P50-053-3526

Device Description : 3.5 x 26 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000330 Catalog Number : P50-053-3528

Device Description : 3.5 x 28 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000347 Catalog Number : P50-053-3530

Device Description : 3.5 x 30 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000354 Catalog Number : P50-053-3532

Device Description : 3.5 x 32 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000361 Catalog Number : P50-053-3534

Device Description : 3.5 x 34 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000378 Catalog Number : P50-053-3536

Device Description : 3.5 x 36 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000385 Catalog Number : P50-053-3538

Device Description : 3.5 x 38 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000392 Catalog Number : P50-053-3540

Device Description : 3.5 x 40 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000408 Catalog Number : P50-053-3542

Device Description : 3.5 x 42 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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