SYNTH™ PLUS

GUDID 08800038058903

IMEDICOM CO., LTD.

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• Primary Device ID: 08800038058903
• NIH Device Record Key: 380b9dac-f094-4472-b71f-fe456ff531a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNTH™ PLUS
• Version Model Number: SYNTH-SPU13
• 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	08800038058903 [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]

• 08800038055650: HC Biologics Private Label(MPU1-B1T1N5-15S)
• 08800038058255: CDS-CP1/ CDS-CF1
• 08800038058248: CDS-BI1/ CDS-BIC1
• 08800038058231: CDS-CA2/ CDS-NDT2
• 08800038058224: CDS-SP1
• 08800038058217: CDS-CA2/ CDS-NDD2
• 08800038058200: CDS-CA2/ CDS-NDB2
• 08800038058194: CDS-CA1/ CDS-NDT1
• 08800038058187: CDS-CA1/ CDS-NDD1
• 08800038058170: CDS-CA1/ CDS-NDB1
• 08800038058163: HCPE-SR10
• 08800038059245: SYNTH-SPU47
• 08800038059238: SYNTH-SPU46
• 08800038059221: SYNTH-SPU45
• 08800038059214: SYNTH-SPU44
• 08800038059207: SYNTH-SPU43
• 08800038059191: SYNTH-SPU42
• 08800038059184: SYNTH-SPU41
• 08800038059177: SYNTH-SPU40
• 08800038059160: SYNTH-SPU39
• 08800038059153: SYNTH-SPU38
• 08800038059146: SYNTH-SPU37
• 08800038059139: SYNTH-SPU36
• 08800038059122: SYNTH-SPU35
• 08800038059115: SYNTH-SPU34
• 08800038059108: SYNTH-SPU33
• 08800038059092: SYNTH-SPU32
• 08800038059085: SYNTH-SPU31
• 08800038059078: SYNTH-SPU30
• 08800038059061: SYNTH-SPU29
• 08800038059054: SYNTH-SPU28
• 08800038059047: SYNTH-SPU27
• 08800038059030: SYNTH-SPU26
• 08800038059023: SYNTH-SPU25
• 08800038059016: SYNTH-SPU24
• 08800038059009: SYNTH-SPU23
• 08800038058996: SYNTH-SPU22
• 08800038058989: SYNTH-SPU21
• 08800038058972: SYNTH-SPU20
• 08800038058965: SYNTH-SPU19
• 08800038058958: SYNTH-SPU18
• 08800038058941: SYNTH-SPU17
• 08800038058934: SYNTH-SPU16
• 08800038058927: SYNTH-SPU15
• 08800038058910: SYNTH-SPU14
• 08800038058903: SYNTH-SPU13
• 08800038058897: SYNTH-SPU12
• 08800038058880: SYNTH-SPU11
• 08800038058873: SYNTH-SPU10
• 08800038058866: SYNTH-SPU9