Distraction Screw, 14MM pouch

GUDID 10818614022588

Surgix Distraction Screw, 14MM pouch

Maruho Medical, Inc.

Intraoperative bone pin/screw, sterile

• Primary Device ID: 10818614022588
• NIH Device Record Key: ccfa6fee-da16-454d-9188-4fb759c11ac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distraction Screw, 14MM pouch
• Version Model Number: SM-0089
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818614022581 [Primary]
GS1	10818614022588 [Package]; Contains: 00818614022581; Package: Box [5 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-09
• Device Publish Date: 2022-09-01

On-Brand Devices [Distraction Screw, 14MM pouch]

• 10818614022588: Surgix Distraction Screw, 14MM pouch
• 00818614022567: Synergy Distraction Screw, 14MM pouch