Triangel

GUDID 06976492570335

TRIANGEL RSD LIMITED

General/multiple surgical diode laser system

• Primary Device ID: 06976492570335
• NIH Device Record Key: d98481fa-3dad-416f-a437-7aaf80e7658b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triangel
• Version Model Number: ST-AR
• Company DUNS: 541194447
• Company Name: TRIANGEL RSD LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976492570335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212734

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2024-08-20
• Device Publish Date: 2024-08-12