Hana ACP UP.PL.0238

GUDID 08800039800143

HANA ACP Uni-Plate 2-level L38

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID08800039800143
NIH Device Record Key7ae4d74c-0a88-4c15-b375-10a3505dda30
Commercial Distribution StatusIn Commercial Distribution
Brand NameHana ACP
Version Model NumberA
Catalog NumberUP.PL.0238
Company DUNS557795909
Company NameDIOMEDICAL CO.,LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800039800143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

[08800039800143]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-18
Device Publish Date2019-02-08

On-Brand Devices [Hana ACP]

08800039800792Pre-set angle Drill Guide
08800039800785Variable angle Drill Guide
08800039800778DTS Guide, Center hole
08800039800761DTS Guide, end hole
08800039800747Plate holder
08800039876629Variable self Drilling Screw D5.1 x L24
08800039876612Variable self Drilling Screw D5.1 x L22
08800039876605Variable self Drilling Screw D4.6 x L26
08800039876599Variable self Drilling Screw D4.6 x L24
08800039876582Variable self Drilling Screw D4.6 x L22
08800113935525Hana Fixed Angle Screw (Self-Drilling) (L)26x(D)5.1mm-Ti color
08800113935518Hana Fixed Angle Screw (Self-Drilling) (L)24x(D)5.1mm-Ti color
08800113935501Hana Fixed Angle Screw (Self-Drilling) (L)22x(D)5.1mm-Ti color
08800113935495Hana Fixed Angle Screw (Self-Drilling) (L)26x(D)4.6mm-Blue
08800113935488Hana Fixed Angle Screw (Self-Drilling) (L)24x(D)4.6mm-Blue
08800113935471Hana Fixed Angle Screw (Self-Drilling) (L)22x(D)4.6mm-Blue
08800039800877Cervical Awl, for Drill Guide
08800039800860Cervical Awl, with Sleeve
08800039800891Cervical Tap
08800039800884Temporary Fixation pin
08800039800709Fixed-angle screws (self-tapping) D5.1 x L26
08800039800693Fixed-angle screws (self-tapping) D5.1 x L24
08800039800686Fixed-angle screws (self-tapping) D5.1 x L22
08800039800679Fixed-angle screws (self-tapping) D5.1 x L20
08800039800662Fixed-angle screws (self-tapping) D5.1 x L18
08800039800655Fixed-angle screws (self-tapping) D5.1 x L16
08800039800648Fixed-angle screws (self-tapping) D5.1 x L14
08800039800631Fixed-angle screws (self-tapping) D5.1 x L12
08800039800624Fixed-angle screws (self-tapping) D4.6 x L26
08800039800617Fixed-angle screws (self-tapping) D4.6 x L24
08800039800600Fixed-angle screws (self-tapping) D4.6 x L22
08800039800594Fixed-angle screws (self-tapping) D4.6 x L20
08800039800587Fixed-angle screws (self-tapping) D4.6 x L18
08800039800570Fixed-angle screws (self-tapping) D4.6 x L16
08800039800563Fixed-angle screws (self-tapping) D4.6 x L14
08800039800556Fixed-angle screws (self-tapping) D4.6 x L12
08800039800549Fixed-angle screws (self-drilling) D5.1 x L20
08800039800532Fixed-angle screws (self-drilling) D5.1 x L18
08800039800525Fixed-angle screws (self-drilling) D5.1 x L16
08800039800518Fixed-angle screws (self-drilling) D5.1 x L14
08800039800501Fixed-angle screws (self-drilling) D5.1 x L12
08800039800495Fixed-angle screws (self-drilling) D4.6 x L20
08800039800488Fixed-angle screws (self-drilling) D4.6 x L18
08800039800471Fixed-angle screws (self-drilling) D4.6 x L16
08800039800464Fixed-angle screws (self-drilling) D4.6 x L14
08800039800457Fixed-angle screws (self-drilling) D4.6 x L12
08800039800440Variable-angle screws (self-tapping) D5.1 x L26
08800039800433Variable-angle screws (self-tapping) D5.1 x L24
08800039800426Variable-angle screws (self-tapping) D5.1 x L22
08800039800419Variable-angle screws (self-tapping) D5.1 x L20
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