Fixone Instrument

GUDID 08800039100618

This instrument is intended to make a drilling path for orthopedic bone screws.

AJU PHARM. CO., LTD.

Bone awl, reusable

• Primary Device ID: 08800039100618
• NIH Device Record Key: 12235ae6-c624-4096-ae19-3e76b221aa55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixone Instrument
• Version Model Number: Fixone.I.B-Awl450ak
• Company DUNS: 963422810
• Company Name: AJU PHARM. CO., LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039100618 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

[08800039100618]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-14
• Device Publish Date: 2025-01-06

On-Brand Devices [Fixone Instrument]

• 08800039102209: This product is a medical cutting tool that is used in connection with an electric medical handp
• 08800039102186: Instrument used to guide the implant or another instrument to the surgical site.
• 08800039102179: Instrument used to measure the depth of lesion.
• 08800039102162: This device is used to support the direction and depth of the drill bit during surgery.
• 08800039102155: This device is used to support the direction and depth of the drill bit during surgery.
• 08800039102148: This device is used to support the direction and depth of the drill bit during surgery.
• 08800039100717: This device is used to drill a hole when inserting Fixone Interference screw.
• 08800039100700: This device is used to drill a hole when inserting Fixone Interference screw.
• 08800039100694: This device is used to support the direction and depth of the drill bit during surgery.
• 08800039100687: This device is used to support the direction and depth of the drill bit during surgery.
• 08800039100670: This device is used to drill a hole in the bone.
• 08800039100663: Instrument used to mark or guide the implant or another instrument to the surgical site.
• 08800039100656: This device is used to drill a hole.
• 08800039100649: This instrument is intended to make a drilling path for orthopedic bone screws.
• 08800039100632: This instrument is intended to make a drilling path for orthopedic bone screws.
• 08800039100625: This instrument is intended to make a drilling path for orthopedic bone screws.
• 08800039100618: This instrument is intended to make a drilling path for orthopedic bone screws.