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

• 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
• 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