Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer

GUDID M678DPLS400W0

Xenon Lightsource, 400 Watt, Digital

SUNOPTIC TECHNOLOGIES LLC

General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source

• Primary Device ID: M678DPLS400W0
• NIH Device Record Key: b9a9c21d-5e0a-41ce-95cd-951de59014ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer
• Version Model Number: DPLS-02, DPLS-04
• Company DUNS: 094586898
• Company Name: SUNOPTIC TECHNOLOGIES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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
HIBCC	M678DPLS400W0 [Primary]

FDA Product Code

• FSS: Light, Surgical, Floor Standing

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-09
• Device Publish Date: 2023-03-01

On-Brand Devices [Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer]

• M678DPLS300W0: Xenon Lightsource, 300 Watt, Digital
• M678SLSS0: Battery powered light source for illumination of a surgical field.
• M678DPLS400W0: Xenon Lightsource, 400 Watt, Digital