AlloSource 20mm ProChondrix Drill/Guide

GUDID 00818614021829

Single-use disposable orthopedic manual surgical instrument

Maruho Medical, Inc.

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• Primary Device ID: 00818614021829
• NIH Device Record Key: 146d1125-3150-41a1-80f9-aff069f30ad5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlloSource 20mm ProChondrix Drill/Guide
• Version Model Number: 58160-20
• Company DUNS: 117630237
• Company Name: Maruho Medical, Inc.
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818614021829 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-16
• Device Publish Date: 2022-03-08

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• 10818614022618 - Distraction Pin, 14MM pouch: 2023-06-02 Sharp Distraction Pin, 14MM pouch
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