TDM Co., Ltd.

Address:69, Cheomdan Venture so-ro 37beon-gil,Gwangju,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

Plate, Fixation, Bone (HRS) (5)

Premarket Exempt

Clear

N/A - 08809517539568 Catalog Number : PCF-817S

Device Description : Bridge Fixator *1.2mm, 16H

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539575 Catalog Number : PCF-410S

Device Description : Hinge Plate *65X14X3

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539582 Catalog Number : PCF-411S

Device Description : Hinge Plate *65X14X1.5

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539599 Catalog Number : PCD-600S

Device Description : Xpert type *60X16.5

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539605 Catalog Number : PCD-601S

Device Description : Xpert type

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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