CATALYST ORTHOSCIENCE INC.

Address:14710 Tamiami Trail N., Suite #102,Naples,FL,34110,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

Shoulder Prosthesis, Reverse Configuration (PHX) (10)

Premarket Exempt

No Yes

Clear

R1 Reverse Shoulder System - 00811596030568 Catalog Number :

Device Description : Center Screw 6.5mm - 40mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030575 Catalog Number :

Device Description : Center Post 6.5mm - 25mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030582 Catalog Number :

Device Description : Center Post 6.5mm - 35mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030599 Catalog Number :

Device Description : Peripheral Screw 4.5mm - 12mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030605 Catalog Number :

Device Description : Peripheral Screw 4.5mm - 16mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030612 Catalog Number :

Device Description : Peripheral Screw 4.5mm - 20mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030629 Catalog Number :

Device Description : Peripheral Screw 4.5mm - 24mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030636 Catalog Number :

Device Description : Peripheral Screw 4.5mm - 28mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030643 Catalog Number :

Device Description : Peripheral Screw 4.5mm - 32mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030650 Catalog Number :

Device Description : Peripheral Screw 4.5mm - 36mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

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