TRIMED, INCORPORATED

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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) (4) BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL (GFA) (2) Plate, fixation, bone (HRS) (2) TRAY, SURGICAL, INSTRUMENT (FSM) (1)

Premarket Exempt

No Yes

Clear

SmallThreadedIMNail 3.0mm (sst) - 00842188124815 Catalog Number : IMN3.0-55 S

Device Description : Threaded IM Nail 3.0mm, 55mm, SS

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

SmallThreadedIMNail 3.0mm (sst) - 00842188124822 Catalog Number : IMN3.0-60 S

Device Description : Threaded IM Nail 3.0mm, 60mm, SS

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

SmallThreadedIMNail 3.0mm (sst) - 00842188124839 Catalog Number : IMN3.0-65 S

Device Description : Threaded IM Nail 3.0mm, 65mm, SS

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

SmallThreadedIMNail 3.0mm (sst) - 00842188124846 Catalog Number : IMN3.0-70 S

Device Description : Threaded IM Nail 3.0mm, 70mm, SS

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Saw Blades - 00842188124853 Catalog Number : OSB-LS

Device Description : Saw Blade Oscillating, Long, S-type

Device Class : 1

Duns Number: 138041277

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : No

Device Count : 1

Saw Blades - 00842188124860 Catalog Number : OSB-LM

Device Description : Saw Blade Oscillating, Long, M-type

Device Class : 1

Duns Number: 138041277

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : No

Device Count : 1

Clavicle Plates - 00842188124877 Catalog Number : CPSMLTL-8

Device Description : Superior Mediolateral Plate, Lt, 8-Hole

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Clavicle Plates - 00842188124884 Catalog Number : CPSMLTR-8

Device Description : Superior Mediolateral Plate, Rt, 8-Hole

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Generic Instruments - 00842188124891 Catalog Number : RFID-TAG

Device Description : RFID Tag

Device Class : 1

Duns Number: 138041277

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

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