SYNTH™ BES

GUDID 08800038056336

IMEDICOM CO., LTD.

Balloon kyphoplasty kit

• Primary Device ID: 08800038056336
• NIH Device Record Key: fb81735c-4013-4cbf-a857-212651620aaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNTH™ BES
• Version Model Number: SYNTH-BESX
• 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	08800038056336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153296

FDA Product Code

• NDN: Cement, Bone, 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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [SYNTH™ BES]

• 08800038056176: SYNTH BESX
• 08800038056169: SYNTH BES20
• 08800038056152: SYNTH BES15
• 08800038056145: SYNTH BES10
• 08800038056336: SYNTH-BESX
• 08800038056329: SYNTH-BES20
• 08800038056312: SYNTH-BES15
• 08800038056305: SYNTH-BES10