Rebuilder Nerve Guidance Conduit

GUDID 06975222390083

Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.

Nerve guide, synthetic polymer, bioabsorbable

• Primary Device ID: 06975222390083
• NIH Device Record Key: 3e21f310-53d3-4164-b4cd-d4201d8e1de4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rebuilder Nerve Guidance Conduit
• Version Model Number: TG-080
• Company DUNS: 702939498
• Company Name: Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	06975222390083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230794

FDA Product Code

• JXI: Cuff, Nerve

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: 2025-05-28
• Device Publish Date: 2025-05-20

On-Brand Devices [Rebuilder Nerve Guidance Conduit]

• 06975222390090: TG-100
• 06975222390083: TG-080
• 06975222390076: TG-070
• 06975222390069: TG-060
• 06975222390052: TG-050
• 06975222390045: TG-040
• 06975222390038: TG-030
• 06975222390021: TG-025
• 06975222390014: TG-020
• 06975222390007: TG-015