Confocal Microprobe Imaging System

GUDID 06971679949935

Wuxi Hisky Medical Technologies Co.,Ltd.

Confocal endomicroscopy system

• Primary Device ID: 06971679949935
• NIH Device Record Key: c38558e9-bc26-4ba2-a56b-ea50d30487db
• Commercial Distribution Discontinuation: 2025-08-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Confocal Microprobe Imaging System
• Version Model Number: BrightX66
• Company DUNS: 544348534
• Company Name: Wuxi Hisky Medical Technologies Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	06971679949935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243711

FDA Product Code

• OWN: Confocal Optical Imaging

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06971679949935]

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[06971679949935]

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[06971679949935]

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[06971679949935]

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[06971679949935]

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[06971679949935]

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[06971679949935]

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[06971679949935]

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[06971679949935]

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[06971679949935]

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[06971679949935]

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[06971679949935]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-22
• Device Publish Date: 2025-08-14

On-Brand Devices [Confocal Microprobe Imaging System]

• 06971679949935: BrightX66
• 06971679949928: BrightP100
• 06971679949911: BrightP160
• 06971679949904: BrightP200
• 06971679949898: BrightP280
• 06971679949881: BrightP580
• 06971679949874: BrightP600
• 06971679949867: BrightP660
• 06971679949850: BrightP680
• 06971679949843: BrightP750
• 06971679949836: BrightP780
• 06971679949829: BrightP860
• 06971679949812: BrightP880
• 06971679949805: BrightP900
• 06971679949799: BrightP960
• 06971679949782: BrightP980