GS Medical Co., Ltd.

Address:90, Osongsaengmyeong 4-ro, Osong-eup,,Heungdeok-gu, Cheongju-si Chungbuk,KR

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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

Orthopedic Manual Surgical Instrument (LXH) (7) Tray, Surgical, Instrument (FSM) (2) Gauge, Depth (HTJ) (1)

Premarket Exempt

No Yes

Clear

AnyPlus® - 08809695609602 Catalog Number : US114-9092

Device Description : Anyplus MIS NX System Implants Tray

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

AnyPlus® - 08809695609619 Catalog Number : US114-9001

Device Description : Tower

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AnyPlus® - 08809695609626 Catalog Number : US114-9003

Device Description : Dilator 1

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AnyPlus® - 08809695609633 Catalog Number : US114-9004

Device Description : Dilator 2

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AnyPlus® - 08809695609640 Catalog Number : US114-9005

Device Description : Dilator 3

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AnyPlus® - 08809695609657 Catalog Number : US114-9006

Device Description : Emg Sleeve

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AnyPlus® - 08809695609671 Catalog Number : US114-9013

Device Description : Torque Stabilizer

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AnyPlus® - 08809695609695 Catalog Number : US114-9028

Device Description : Rod Reduction-External

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AnyPlus® - 08809695609701 Catalog Number : US114-9011

Device Description : Rod Gauge

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

AnyPlus® - 08809695617300 Catalog Number : US114-9990

Device Description : AnyPlus MIS NX Instruments Tray

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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