MEDINAUT Flex

GUDID 08800038044944

IMEDICOM CO., LTD.

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 08800038044944
• NIH Device Record Key: 1c8c8514-00c8-4450-852e-32713a81dcd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDINAUT Flex
• Version Model Number: MDF1
• Company DUNS: 690340653
• Company Name: IMEDICOM CO., LTD.
• 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: 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	08800038044944 [Primary]

FDA Product Code

• OCJ: Spinal Channeling Instrument, Vertebroplasty

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: 2020-10-26
• Device Publish Date: 2020-10-16

Devices Manufactured by IMEDICOM CO., LTD.

• 08800038059894 - MEDINAUT MAX: 2024-11-25 Battery Shield
• 08800038059863 - MEDINAUT MAX: 2024-11-22 4cell Battery
• 08800038059870 - MEDINAUT MAX: 2024-11-22 4cell Battery Case
• 08800038059887 - MEDINAUT MAX: 2024-11-22 2ch Charger
• 08800038056114 - IMEDICOM SAW BLADE: 2024-11-20
• 08800038056121 - IMEDICOM SAW BLADE: 2024-11-20
• 08404535005516 - Brasseler EZX: 2024-09-16 Side handle for Brasseler EZX offset shaft
• 00887919993124 - Brasseler EZX: 2024-05-07