Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer ROVER SLS-S

GUDID M678SLSS0

Battery powered light source for illumination of a surgical field.

SUNOPTIC TECHNOLOGIES LLC

Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light

• Primary Device ID: M678SLSS0
• NIH Device Record Key: ddf1c94f-b6f6-41c6-a38d-f8e37f7feb81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer
• Version Model Number: ROVER SLS
• Catalog Number: ROVER SLS-S
• 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in cool dry location

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M678SLSS0 [Primary]
HIBCC	M678SLSS1 [Package]; Package: [5 Units]; In Commercial Distribution
HIBCC	M678SLSS3 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• FCW: Light Source, Fiberoptic, Routine

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: 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