MEDINAUT Plus Kyphoplasty System

GUDID 08809544175319

IMEDICOM CO., LTD.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 08809544175319
• NIH Device Record Key: c99b8cd4-c3c8-4893-939d-dda417e83430
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDINAUT Plus Kyphoplasty System
• Version Model Number: PIBE-SR10
• 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	08809544175319 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-05-31

On-Brand Devices [MEDINAUT Plus Kyphoplasty System]

• 08800038038370: MPU1-B2N5-15S
• 08809544175319: PIBE-SR10
• 08809544175173: PIBE-B00
• 08800038028876: N/A