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 - 08800043900105 Catalog Number : PPE-216

Device Description : Modified Pectus Bar - Rounded end *16.0Inch, (406.4mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900112 Catalog Number : PPE-217

Device Description : Modified Pectus Bar - Rounded end *17.0Inch, (431.8mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900129 Catalog Number : PPE-207H

Device Description : Modified Pectus Bar - Rounded end *7.5Inch, (190.5mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900136 Catalog Number : PPE-208H

Device Description : Modified Pectus Bar - Rounded end *8.5Inch, (215.9mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900143 Catalog Number : PPE-209H

Device Description : Modified Pectus Bar - Rounded end *9.5Inch, (241.3mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900150 Catalog Number : PPE-210H

Device Description : Modified Pectus Bar - Rounded end *10.5Inch, (266.7mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900167 Catalog Number : PPE-211H

Device Description : Modified Pectus Bar - Rounded end *11.5Inch, (292.1mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900174 Catalog Number : PPE-212H

Device Description : Modified Pectus Bar - Rounded end *12.5Inch, (317.5mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900181 Catalog Number : PPE-213H

Device Description : Modified Pectus Bar - Rounded end *13.5Inch, (342.9mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900198 Catalog Number : PPE-214H

Device Description : Modified Pectus Bar - Rounded end *14.5Inch, (368.3mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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