Epix Orthopaedics Inc.

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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

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES (HSB) (9) GAUGE, DEPTH (HTJ) (1)

Premarket Exempt

Clear

EPIX Depth Gauge - B221100000100 Catalog Number : 1000-0010

Device Description : Depth Gauge

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

EPIX VAN - B2213110205111 Catalog Number : 3110-20511

Device Description : Intramedullary And Accessories

Device Class : 2

Duns Number: 084913303

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

EPIX Assy, VAN, 10mm Dia, 205mm - B2213210205101 Catalog Number : 3210-20510

Device Description : Intramedullary And Accessories

Device Class : 2

Duns Number: 084913303

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

EPIX Assy, Long Nail 10mm x 280mm Left - B221321028010L1 Catalog Number : 3210-28010L

Device Description : Intramedullary And Accessories

Device Class : 2

Duns Number: 084913303

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

EPIX Assy, Long Nail 10mm x 280mm Right - B221321028010R1 Catalog Number : 3210-28010R

Device Description : Intramedullary And Accessories

Device Class : 2

Duns Number: 084913303

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

EPIX Assy, Long Nail 10mm x 300mm Left - B221321030010L1 Catalog Number : 3210-30010L

Device Description : Intramedullary And Accessories

Device Class : 2

Duns Number: 084913303

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

EPIX Assy, Long Nail 10mm x 300mm Right - B221321030010R1 Catalog Number : 3210-30010R

Device Description : Intramedullary And Accessories

Device Class : 2

Duns Number: 084913303

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

EPIX Assy, Long Nail 10mm x 320mm Left - B221321032010L1 Catalog Number : 3210-32010L

Device Description : Intramedullary And Accessories

Device Class : 2

Duns Number: 084913303

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

EPIX Assy, Long Nail 10mm x 320mm Right - B221321032010R1 Catalog Number : 3210-32010R

Device Description : Intramedullary And Accessories

Device Class : 2

Duns Number: 084913303

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

EPIX Assy, Long Nail 10mm x 340mm Left - B221321034010L1 Catalog Number : 3210-34010L

Device Description : Intramedullary And Accessories

Device Class : 2

Duns Number: 084913303

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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