Pega Medical Inc

Address:1111 Chomedey Highway (A13),Laval Quebec,CA

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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) (10)

Premarket Exempt

No Yes

Clear

FASSIER-DUVAL TELESCOPIC IM SYSTEM - 07540194000217 Catalog Number : T032-SS

Device Description : Tibia/Humeral Female Component for Ø3.2mm Assy

Device Class : 2

Duns Number: 257315713

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

FASSIER-DUVAL TELESCOPIC IM SYSTEM - 07540194000224 Catalog Number : T040-SS

Device Description : Tibia/Humeral Female Component for Ø4.0mm Assy

Device Class : 2

Duns Number: 257315713

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

FASSIER-DUVAL TELESCOPIC IM SYSTEM - 07540194000231 Catalog Number : T048-SS

Device Description : Tibia/Humeral Female Component for Ø4.8mm Assy

Device Class : 2

Duns Number: 257315713

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

FASSIER-DUVAL TELESCOPIC IM SYSTEM - 07540194000248 Catalog Number : T056-SS

Device Description : Tibia/Humeral Female Component for Ø5.6mm Assy

Device Class : 2

Duns Number: 257315713

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

FASSIER-DUVAL TELESCOPIC IM SYSTEM - 07540194000255 Catalog Number : T064-SS

Device Description : Tibia/Humeral Female Component for Ø6.4mm Assy

Device Class : 2

Duns Number: 257315713

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

FASSIER-DUVAL TELESCOPIC IM SYSTEM - 07540194000262 Catalog Number : FD-032(L)-SS

Device Description : Long Femoral Nail Assy Ø3.2mm

Device Class : 2

Duns Number: 257315713

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

FASSIER-DUVAL TELESCOPIC IM SYSTEM - 07540194000279 Catalog Number : FD-032(S)-SS

Device Description : Short Femoral Nail Assy Ø3.2 mm

Device Class : 2

Duns Number: 257315713

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

FASSIER-DUVAL TELESCOPIC IM SYSTEM - 07540194000286 Catalog Number : FD-032(SPL)-SS

Device Description : Short Proximal Long Distal Nail Assy Ø3.2 mm

Device Class : 2

Duns Number: 257315713

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

FASSIER-DUVAL TELESCOPIC IM SYSTEM - 07540194000293 Catalog Number : FD-032(SPS)-SS

Device Description : Short Tibial/Humeral Nail Assy Ø3.2 mm

Device Class : 2

Duns Number: 257315713

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

FASSIER-DUVAL TELESCOPIC IM SYSTEM - 07540194000309 Catalog Number : FDLON-F032-SS

Device Description : LON Femoral Nail Assy Ø3.2 mm

Device Class : 2

Duns Number: 257315713

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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