SYNTH™ STANDARD

GUDID 08800038059344

IMEDICOM CO., LTD.

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• Primary Device ID: 08800038059344
• NIH Device Record Key: 4939d8eb-1ced-49c2-87d6-9d5da77ab106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNTH™ STANDARD
• Version Model Number: SYNTH-SSU10D
• 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	08800038059344 [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™ STANDARD]

• 08800038055643: BC Biologics Private Label(MKU15)
• 08800038059344: SYNTH-SSU10D
• 08800038059337: SYNTH-SSUD
• 08800038059320: SYNTH-SSU20D
• 08800038059313: SYNTH-SSU10
• 08800038059306: SYNTH-SSU20