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

Tray, Surgical, Instrument (FSM) (5) Arthroscope (HRX) (3) Cement, Bone, Vertebroplasty (NDN) (3) Bit, Drill (HTW) (1) Clamp (HXD) (1)

Premarket Exempt

No Yes

Clear

Tracker Plus Kyphoplasty System - 08809695579790 Catalog Number : GSB-1110

Device Class : 2

Duns Number: 688385418

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

Tracker Plus Kyphoplasty System - 08809695579806 Catalog Number : GCD-N1300

Device Class : 2

Duns Number: 688385418

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

Tracker Plus Kyphoplasty System - 08809695579998 Catalog Number : GSMD-11

Device Class : 2

Duns Number: 688385418

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

AnyPlus® - 08809695600418 Catalog Number : GS138-7101

Device Description : Bed Rail Clamp

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : HXD

Prescription Use : Yes

Device Count : 1

CASSIOPEIA ACP - 08809695601163 Catalog Number : GS142-1004

Device Description : Double Barrel DTS Guide, Short Barrel

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

CASSIOPEIA ACP - 08809695602146 Catalog Number : GS112-9632

Device Description : Cervical Plate 2 LEVEL Caddy

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

CASSIOPEIA ACP - 08809695602153 Catalog Number : GS112-9633

Device Description : Cervical Plate 3 LEVEL Caddy

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

CASSIOPEIA ACP - 08809695602160 Catalog Number : GS112-9634

Device Description : Cervical Plate Temporary Pin Caddy

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

CASSIOPEIA ACP - 08809695606205 Catalog Number : GS142-1020

Device Description : Drill Bit, 20mm

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

CASSIOPEIA ACP - 08809695608353 Catalog Number : GS142-1005

Device Description : Double Barrel DTS Guide, Long Barrel

Device Class : 1

Duns Number: 688385418

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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