restor3d Guidewire

GUDID 00840097522708

Guidewire, Single Trocar, 1.6mm x 5"

Restor3d, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00840097522708
• NIH Device Record Key: c7ca6faf-d1c8-45d9-b7d1-6a5b19abd3e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Guidewire
• Version Model Number: 6202-165
• Company DUNS: 080819836
• Company Name: Restor3d, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840097522708 [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: 2025-05-30
• Device Publish Date: 2025-05-22

Devices Manufactured by Restor3d, Inc.

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• 00840097513263 - Ossera™ AFX Instrumentation: 2025-12-26 Ossera AFX™ Flat Cut Guide
• 00840097513270 - Ossera™ AFX Instrumentation: 2025-12-26 Ossera AFX™ Distractor
• 00840097513287 - Ossera™ AFX Instrumentation: 2025-12-26 Ossera AFX™ Trial, Cylinder, 34D x 26H
• 00840097515724 - Ossera™ AFX Instrumentation: 2025-12-26 Ossera AFX™ Trial, Cylinder, 34D x 36H
• 00840097515731 - Ossera™ AFX Instrumentation: 2025-12-26 Ossera AFX™ Trial, Cylinder, 34D x 40H
• 00840097519333 - Ossera™ AFX: 2025-12-26 Ossera™ AFX, Cylinder, 34x26
• 00840097519340 - Ossera™ AFX: 2025-12-26 Ossera™ AFX, Cylinder, 34x36