Halo Sterile Single-use Radial Fiber

GUDID 06976712970266

Micro-Energy Medical Technology Co., Ltd

General/multiple surgical laser system beam guide, single-use

• Primary Device ID: 06976712970266
• NIH Device Record Key: 686a817c-8093-4e07-be62-fb5530b89b57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halo Sterile Single-use Radial Fiber
• Version Model Number: Novo-R-0.40-1.8
• Company DUNS: 620289544
• Company Name: Micro-Energy Medical Technology Co., Ltd
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976712970266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252745

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2025-12-29
• Device Publish Date: 2025-12-20

On-Brand Devices [Halo Sterile Single-use Radial Fiber]

• 06976712970273: Novo-R-0.60-1.8
• 06976712970266: Novo-R-0.40-1.8
• 06976712970259: Halo-R-0.60-2.5
• 06976712970242: Halo-R-0.40-2.5