TracLux TLC1353-SLSU

GUDID M678TLCSLS0

TracLux SLS-S, Battery Operated Lightsource

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

• Primary Device ID: M678TLCSLS0
• NIH Device Record Key: c8e9916e-143a-45ca-8279-dd512ba97143
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TracLux
• Version Model Number: TracLux-SLS
• Catalog Number: TLC1353-SLSU
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M678TLCSLS0 [Primary]
HIBCC	M678TLCSLS1 [Package]; Package: [5 Units]; In Commercial Distribution
HIBCC	M678TLCSLS3 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• FSZ: Light, Surgical, Carrier

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-28
• Device Publish Date: 2023-05-29

On-Brand Devices [TracLux]

• M678TLC0: TRACLUX Light Carrier, Sterile, Single Use, and accessories
• M678HHR0: Hand Held Retractor and accessories
• M678TLCSLS0: TracLux SLS-S, Battery Operated Lightsource