Gramedica

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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) Plate, Fixation, Bone (HRS) (4)

Premarket Exempt

No Yes

Clear

osteo-WEDGE Opening Wedge Bone Locking System - M621CARRYINGCASE0 Catalog Number : CarryingCase

Device Description : osteo-WEDGE Opening Wedge Bone Locking System -Kit (containing non-sterile singl

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

osteo-WEDGE2 Open Wedge Bone Locking System - M621CARRYINGCASE20 Catalog Number : CarryingCase2

Device Description : osteo-WEDGE2 Opening Wedge Bone Locking System -Kit (containing non-sterile sing

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

HyProCure Sizer 05 - M621CP1505FG0 Catalog Number : CP15-05-FG

Device Description : HyProCure Sizer 05. Reusable instrument, for use with the HyProCure Sinus Tarsi

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure Sizer 06 - M621CP1506FG0 Catalog Number : CP15-06-FG

Device Description : HyProCure Sizer 06. Reusable instrument, for use with the HyProCure Sinus Tar

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure Sizer 07 - M621CP1507FG0 Catalog Number : CP15-07-FG

Device Description : HyProCure Sizer 07. Reusable instrument, for use with the HyProCure Sinus Tars

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure Sizer 08 - M621CP1508FG0 Catalog Number : CP15-08-FG

Device Description : HyProCure Sizer 08. Reusable instrument, for use with the HyProCure Sinus Tars

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure Sizer 09 - M621CP1509FG0 Catalog Number : CP15-09-FG

Device Description : HyProCure Sizer 09. Reusable instrument, for use with the HyProCure Sinus Tars

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure Sizer 10 - M621CP1510FG0 Catalog Number : CP15-10-FG

Device Description : HyProCure Sizer 10. Reusable instrument, for use with the HyProCure Sinus Tar

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

osteo-WEDGE Depth Gauge Sleeve - M621GM150010 Catalog Number : GM-150-01

Device Description : osteo-WEDGE Depth Gauge Sleeve, a reusable instrument, for use with the osteo-WE

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

osteo-WEDGE Depth Gauge - M621GM150020 Catalog Number : GM-150-02

Device Description : osteo-WEDGE Depth Gauge, a reusable instrument, for use with the osteo-WEDGE Op

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

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