FC-001 FC-001

GUDID 00816469021414

Ceramic Fiber Cleaver

LASER PERIPHERALS, LLC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00816469021414
• NIH Device Record Key: 4ed6c23b-a340-46f5-b541-3f8f130a8287
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FC-001
• Version Model Number: FC-001
• Catalog Number: FC-001
• Company DUNS: 177234754
• Company Name: LASER PERIPHERALS, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00816469021414 [Primary]

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: 2019-12-10
• Device Publish Date: 2019-12-02

Devices Manufactured by LASER PERIPHERALS, LLC

• 00816469021674 - LG-200-CN: 2024-12-16 LaseGuide® Connect 200u Laser Fiber
• 00816469021681 - LG-200-CN-PL: 2024-12-16 LaseGuide® Connect 200u Laser Fiber PL
• 00816469021650 - LG-T200: 2024-07-23 272/200um Tapered HP Laser Fiber
• 00816469021667 - LG-T200-PL: 2024-07-23 272/200um Tapered HP Laser Fiber PL
• 00816469021629 - DBSS-272: 2022-05-30 272u Laser Fiber
• 00816469021636 - DBSS-272-PL: 2022-05-30 272u Laser Fiber PL
• 00816469021612 - DB-600R-5: 2021-11-29 600u Reduced Buffer Laser Fiber 5 use
• 00816469021599 - HTB-800: 2021-03-30 800u Laser Fiber