SYNTH™ PLUS BILATERAL

GUDID 08800038058736

IMEDICOM CO., LTD.

Balloon kyphoplasty kit

• Primary Device ID: 08800038058736
• NIH Device Record Key: e5bf1f58-f29b-49a8-910d-f57f5d5fa155
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNTH™ PLUS BILATERAL
• Version Model Number: SYNTH-SPB43
• 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	08800038058736 [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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [SYNTH™ PLUS BILATERAL]

• 08800038055667: HC Biologics Private Label(MPB1-B1T1N10-15S)
• 08800038058774: SYNTH-SPB47
• 08800038058767: SYNTH-SPB46
• 08800038058750: SYNTH-SPB45
• 08800038058743: SYNTH-SPB44
• 08800038058736: SYNTH-SPB43
• 08800038058729: SYNTH-SPB42
• 08800038058712: SYNTH-SPB41
• 08800038058705: SYNTH-SPB40
• 08800038058699: SYNTH-SPB39
• 08800038058682: SYNTH-SPB38
• 08800038058675: SYNTH-SPB37
• 08800038058668: SYNTH-SPB36
• 08800038058651: SYNTH-SPB35
• 08800038058644: SYNTH-SPB34
• 08800038058637: SYNTH-SPB33
• 08800038058620: SYNTH-SPB32
• 08800038058613: SYNTH-SPB31
• 08800038058606: SYNTH-SPB30
• 08800038058590: SYNTH-SPB29
• 08800038058583: SYNTH-SPB28
• 08800038058576: SYNTH-SPB27
• 08800038058569: SYNTH-SPB26
• 08800038058552: SYNTH-SPB25
• 08800038058545: SYNTH-SPB24
• 08800038058538: SYNTH-SPB23
• 08800038058521: SYNTH-SPB22
• 08800038058514: SYNTH-SPB21
• 08800038058507: SYNTH-SPB20
• 08800038058491: SYNTH-SPB19
• 08800038058484: SYNTH-SPB18
• 08800038058477: SYNTH-SPB17
• 08800038058460: SYNTH-SPB16
• 08800038058453: SYNTH-SPB15
• 08800038058446: SYNTH-SPB14
• 08800038058439: SYNTH-SPB13
• 08800038058422: SYNTH-SPB12
• 08800038058415: SYNTH-SPB11
• 08800038058408: SYNTH-SPB10
• 08800038058392: SYNTH-SPB9
• 08800038058385: SYNTH-SPB8
• 08800038058378: SYNTH-SPB7
• 08800038058361: SYNTH-SPB6
• 08800038058354: SYNTH-SPB5
• 08800038058347: SYNTH-SPB4
• 08800038058330: SYNTH-SPB3
• 08800038058323: SYNTH-SPB2
• 08800038058316: SYNTH-SPB1