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 - 00811596030360 Catalog Number :

Device Description : Humeral Stem Short - 36mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030377 Catalog Number :

Device Description : Humeral Stem Short - 41mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030384 Catalog Number :

Device Description : Humeral Stem Long - 36mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030391 Catalog Number :

Device Description : Humeral Stem Long - 41mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030407 Catalog Number :

Device Description : Poly Insert 32mm +0

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030414 Catalog Number :

Device Description : Poly Insert 32mm +4

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030421 Catalog Number :

Device Description : Poly Insert 32mm +8

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030438 Catalog Number :

Device Description : Poly Insert 32mm +12

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030445 Catalog Number :

Device Description : Poly Insert 36mm +0

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030452 Catalog Number :

Device Description : Poly Insert 36mm +4

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

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