SteriSpine VA

GUDID 08800038029323

MEDINAUT Plus

IMEDICOM CO., LTD.

Balloon kyphoplasty kit

• Primary Device ID: 08800038029323
• NIH Device Record Key: f66d2840-7aa2-44d3-8486-f2eb63c024b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriSpine VA
• Version Model Number: KITKYPHO10
• Company DUNS: 690340653
• Company Name: IMEDICOM CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08800038029323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182287

FDA Product Code

• HRX: Arthroscope

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: 2025-10-02
• Device Publish Date: 2025-09-24

On-Brand Devices [SteriSpine VA ]

• 08800038039476: MEDINAUT Plus
• 08800038039469: MEDINAUT Plus
• 08800038039452: MEDINAUT Plus
• 08800038039445: MEDINAUT Plus
• 08800038039438: MEDINAUT Plus
• 08800038039421: MEDINAUT Plus
• 08800038039414: MEDINAUT Plus
• 08800038039407: MEDINAUT Plus
• 08800038029422: MEDINAUT Plus
• 08800038029415: MEDINAUT Plus
• 08800038029378: MEDINAUT Plus
• 08800038029361: MEDINAUT Plus
• 08800038029354: MEDINAUT Plus
• 08800038029347: MEDINAUT Plus
• 08800038029330: MEDINAUT Plus
• 08800038029323: MEDINAUT Plus