Distraction Screw

GUDID 10818614021413

Distraction Screw, 14MM Patient (Inner)

Maruho Medical, Inc.

Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use

• Primary Device ID: 10818614021413
• NIH Device Record Key: 2aa1ef11-03dd-4bd8-ac4e-8241d259f8b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distraction Screw
• Version Model Number: 909-14
• 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: true
• 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

• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818614021416 [Primary]
GS1	10818614021413 [Package]; Contains: 00818614021416; Package: Caton [10 Units]; In Commercial Distribution

FDA Product Code

• LYQ: Accessories, Fixation, Spinal Intervertebral Body

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-02
• Device Publish Date: 2023-01-26

On-Brand Devices [Distraction Screw]

• 10818614021413: Distraction Screw, 14MM Patient (Inner)
• 10818614021406: Distraction Screw, 12MM Patient (Inner)