Hana ACP UP.IN.0008

GUDID 08800039800785

Variable angle Drill Guide

DIOMEDICAL CO.,LTD.

Surgical drill guide, reusable

• Primary Device ID: 08800039800785
• NIH Device Record Key: 48bbf3e5-bda4-49ed-b22b-2301c731fa85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hana ACP
• Version Model Number: A
• Catalog Number: UP.IN.0008
• Company DUNS: 557795909
• Company Name: DIOMEDICAL CO.,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82313699470
• Email: info@huvexel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039800785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173099

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800039800785]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2019-02-08

On-Brand Devices [Hana ACP]

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