DIOMEDICAL CO.,LTD.

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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

Appliance, fixation, spinal intervertebral body (KWQ) (10)

Premarket Exempt

Clear

Hana ACP - 08800039800013 Catalog Number : UP.PL.0113

Device Description : HANA ACP Uni-Plate 1-level L13

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800020 Catalog Number : UP.PL.0115

Device Description : HANA ACP Uni-Plate 1-level L15

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800037 Catalog Number : UP.PL.0117

Device Description : HANA ACP Uni-Plate 1-level L17

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800044 Catalog Number : UP.PL.0119

Device Description : HANA ACP Uni-Plate 1-level L19

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800051 Catalog Number : UP.PL.0121

Device Description : HANA ACP Uni-Plate 1-level L21

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800068 Catalog Number : UP.PL.0123

Device Description : HANA ACP Uni-Plate 1-level L23

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800075 Catalog Number : UP.PL.0125

Device Description : HANA ACP Uni-Plate 1-level L25

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800082 Catalog Number : UP.PL.0226

Device Description : HANA ACP Uni-Plate 2-level L26

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800099 Catalog Number : UP.PL.0228

Device Description : HANA ACP Uni-Plate 2-level L28

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800105 Catalog Number : UP.PL.0230

Device Description : HANA ACP Uni-Plate 2-level L30

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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