SYNTH™ CDS

GUDID 08800038059252

IMEDICOM CO., LTD.

Balloon kyphoplasty kit

• Primary Device ID: 08800038059252
• NIH Device Record Key: 2066984f-b6af-4b3f-9035-86872a7eb7d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNTH™ CDS
• Version Model Number: SYNTH-CDS-CAX1
• 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	08800038059252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153296

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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [SYNTH™ CDS]

• 08800038056183: SYNTH CDS
• 08800038056343: SYNTH-CDS
• 08800038059290: SYNTH-CDS-WPP1
• 08800038059283: SYNTH-CDS-SP1
• 08800038059276: SYNTH-CDS-NDP1
• 08800038059269: SYNTH-CDS-CPF1
• 08800038059252: SYNTH-CDS-CAX1