TracLux TLC1353-SLSU

GUDID M678TLCSLS0

TracLux SLS-S, Battery Operated Lightsource

SUNOPTIC TECHNOLOGIES LLC

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