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 - 08800043900204 Catalog Number : PPE-215H

Device Description : Modified Pectus Bar - Rounded end *15.5Inch, (393.7mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900211 Catalog Number : PPE-216H

Device Description : Modified Pectus Bar - Rounded end *16.5Inch, (419.1mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900228 Catalog Number : PPE-306

Device Description : Modified Pectus Bar - Rounded end *6.0Inch, (152.4mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900235 Catalog Number : PPE-307

Device Description : Modified Pectus Bar - Rounded end *7.0Inch, (177.8mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900242 Catalog Number : PPE-308

Device Description : Modified Pectus Bar - Rounded end *8.0Inch, (203.2mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900259 Catalog Number : PPE-309

Device Description : Modified Pectus Bar - Rounded end *9.0Inch, (228.6mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900266 Catalog Number : PPE-310

Device Description : Modified Pectus Bar - Rounded end *10.0Inch, (254.0mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900273 Catalog Number : PPE-311

Device Description : Modified Pectus Bar - Rounded end *11.0Inch, (279.4mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900280 Catalog Number : PPE-312

Device Description : Modified Pectus Bar - Rounded end *12.0Inch, (304.8mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

N/A - 08800043900297 Catalog Number : PPE-313

Device Description : Modified Pectus Bar - Rounded end *13.0Inch, (330.2mm)

Device Class : 2

Duns Number: 557801921

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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