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 - 08800039800112 Catalog Number : UP.PL.0232

Device Description : HANA ACP Uni-Plate 2-level L32

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800129 Catalog Number : UP.PL.0234

Device Description : HANA ACP Uni-Plate 2-level L34

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800136 Catalog Number : UP.PL.0236

Device Description : HANA ACP Uni-Plate 2-level L36

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800143 Catalog Number : UP.PL.0238

Device Description : HANA ACP Uni-Plate 2-level L38

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800150 Catalog Number : UP.PL.0240

Device Description : HANA ACP Uni-Plate 2-level L40

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800167 Catalog Number : UP.PL.0242

Device Description : HANA ACP Uni-Plate 2-level L42

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800174 Catalog Number : UP.PL.0244

Device Description : HANA ACP Uni-Plate 2-level L44

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800181 Catalog Number : UP.PL.0246

Device Description : HANA ACP Uni-Plate 2-level L46

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800198 Catalog Number : UP.VD.4612

Device Description : Variable-angle screws (self-drilling) D4.6 x L12

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800204 Catalog Number : UP.VD.4614

Device Description : Variable-angle screws (self-drilling) D4.6 x L14

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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