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) (10)

Premarket Exempt

Clear

N/A - 08809517539452 Catalog Number : PCF-806S

Device Description : Bridge Fixator *1.0mm, 6H

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539476 Catalog Number : PCF-808S

Device Description : Bridge Fixator *1.0mm, 8H

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539483 Catalog Number : PCF-809S

Device Description : Bridge Fixator *1.2mm, 8H

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539490 Catalog Number : PCF-810S

Device Description : Bridge Fixator *1.0mm, 10H

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539506 Catalog Number : PCF-811S

Device Description : Bridge Fixator *1.2mm, 10H

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539513 Catalog Number : PCF-812S

Device Description : Bridge Fixator *1.0mm, 12H

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539520 Catalog Number : PCF-813S

Device Description : Bridge Fixator *1.2mm, 12H

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539537 Catalog Number : PCF-814S

Device Description : Bridge Fixator *1.0mm, 14H

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539544 Catalog Number : PCF-815S

Device Description : Bridge Fixator *1.2mm, 14H

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08809517539551 Catalog Number : PCF-816S

Device Description : Bridge Fixator *1.0mm, 16H

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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